Devices and methods for treating pelvic floor dysfunctions

ABSTRACT

In one embodiment, an apparatus includes a support portion disposable within a pelvic region and a strap extending from the support portion. The strap has a length and is configured to be disposed at least partially within a pelvic tissue. A sleeve is releasably disposed over at least a portion of the strap. The sleeve has a length that is longer than the length of the strap. In some embodiments, the length of the sleeve is at least twice as long as the length of the strap. In some embodiments, a suture couples the sleeve to the strap. The apparatus can also include a suture disposed at least partially within an interior of the sleeve and forming two strands of suture within the interior of the sleeve. The two strands are separated by a distance defined by a separator portion of the sleeve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of, and claims priority to, U.S.patent application Ser. No. 12/341,695, filed on Dec. 22, 2008, entitled“DEVICES AND METHODS FOR TREATING PELVIC FLOOR DYSFUNCTIONS”, issued asU.S. Pat. No. 8,430,807, which, in turn, claims priority to U.S.Provisional Patent Application No. 61/017,212, filed on Dec. 28, 2007,entitled “DEVICES AND METHODS FOR TREATING PELVIC FLOOR DYSFUNCTIONS”,the disclosures of which are hereby incorporated by reference in theirentirety.

BACKGROUND

The disclosed invention relates generally to medical devices and moreparticularly to implants and methods for delivering implants within apelvic region of a patient to treat various pelvic dysfunctions.

A variety of medical procedures are performed to treat various femalepelvic dysfunctions, including procedures to treat urinary incontinence,and correcting various prolapse conditions such as uterine prolapse,cystoceles, rectoceles, and vaginal vault prolapse.

Women often experience vaginal prolapses due to age or other factors.For example, women may experience a cystocele, a rectocele and/or ahysterocele. A cystocele occurs when the bladder bulges into the vagina,and a rectocele occurs when the rectum bulges into the vagina. Ahysterocele occurs when the uterus descends into the vagina. Anenterocele (small bowel prolapse) can also occur, when the small bowelpushes through the upper wall of the vagina. It is relatively common fora hysterocele and cystocele or hysterocele and rectocele, or othercombinations thereof to occur at the same time. It is also common fordifferent types of prolapse to occur in relatively quick succession.

Treatment has included suturing procedures or the use of implants forsupport or suspension. A hysterocele is often treated with ahysterectomy followed by a vaginal vault suspension. Various devices andprocedures are used to deliver and secure pelvic implants within avariety of different anatomical structures within a pelvic region.Implants can be delivered to a pelvic region through one or more vaginalincisions, and/or through exterior incisions in the patient.

Existing implants differ in many ways including size, shape, material,number and location of straps, and in the method in which they aredelivered and placed within a pelvic region. For example, various sizesof implants are needed to accommodate different sized anatomy and pelvicregions of a patient. For example, if an implant is too large for theparticular patient, damage to surrounding tissue can occur. In somecases, an implant that is too small can increase the chance of prolapserecurrence.

Depending on the particular condition to be treated and the implantused, pelvic floor repair can require various fixation locations withina pelvic region. For example, an implant can be secured using a numberof fixation points. Sutures are often used to bridge, anchor and suspendthe implant in place. Sutures may not provide enough surface area fortissue in-growth, and may require knotting in order to be secured.Implants formed with mesh material can provide for tissue in-growth andthe width of the mesh can help prevent tissue cutting. An implant canalso have roughened or tanged edges to grip surrounding tissue and holdthe mesh implant in place until tissue in-growth occurs. Delivery ofsome implants includes the use of a sleeve to cover some or all of animplant to protect the implant from damage during delivery and toprevent premature engagement of the implant to surrounding tissue.

Various complications can occur during a procedure to deliver and securea pelvic implant due to, for example, space constraints for performingthe implantation procedure. Often, implants can become damaged duringdelivery due to the type of delivery device and/or the type of implant,or due to excessive handling of the implant during the implantprocedure. Thus, it would be desirable to provide improved pelvicimplants and delivery processes associated with such implants to helpprevent damage to the implant during implantation.

SUMMARY OF THE INVENTION

In one embodiment, an apparatus includes a support portion disposablewithin a pelvic region and a strap extending from the support portion.The strap has a length and is configured to be disposed at leastpartially within a pelvic tissue. A sleeve is releasably disposed overat least a portion of the strap. The sleeve has a length that is longerthan the length of the strap. In some embodiments, the length of thesleeve is at least twice as long as the length of the strap. In someembodiments, a suture couples the sleeve to the strap. The apparatus canalso include a suture disposed at least partially within an interior ofthe sleeve and forming two strands of suture within the interior of thesleeve. The two strands are separated by a distance defined by aseparator portion of the sleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an embodiment of an implant.

FIG. 2 is a top view of an embodiment of an implant.

FIG. 3 is a top view of a portion of the implant of FIG. 2.

FIG. 4 is a top view of a strap of the implant of FIG. 2.

FIG. 5 is a side view of a portion of the strap of FIG. 4.

FIG. 6 is an enlarged top view of a portion of the implant of FIG. 2.

FIG. 7 is a side perspective view of a portion of a delivery device.

FIG. 8 is a top view of another embodiment of an anterior implant.

FIG. 9 is a top view of another embodiment of an implant.

FIG. 10 is a top view of a portion of the implant of FIG. 9.

FIG. 11 is a side view of another embodiment of a delivery device.

FIG. 12 is a top view of another embodiment of an implant.

FIG. 13 is a side perspective view of four dilator devices and theimplant of FIG. 12 shown disposed within a schematic illustration ofportions of a pelvic region.

FIG. 14 is a top view of another embodiment of an implant.

FIG. 15 is a side schematic illustration of the implant of FIG. 14 shownpositioned in a pelvic region.

FIGS. 16-21 are each a top view of a different embodiment of an implant.

FIG. 22 is a top view of another embodiment of an implant.

FIG. 23 is a top view of a portion of the implant of FIG. 22 shown withan embodiment of a sleeve assembly coupled to a strap of the implant.

FIG. 24 is a top view of a portion of the implant of FIG. 22 shown withanother embodiment of a sleeve assembly coupled to a strap of theimplant.

FIG. 25 is a side perspective view of the implant of FIG. 22.

FIGS. 26 and 27 are each a top view of a different embodiment of animplant.

FIG. 28-30 are each a top view of a different embodiment of an implant.

FIG. 31 is a top view of a portion of the implant of FIG. 30.

FIG. 32 is a top view of a portion of another embodiment of an implant.

FIGS. 33-36 are each a top view of a different embodiment of a sleeveassembly coupled to a portion of an implant.

FIGS. 37 and 38 are each a top view of a different embodiment of animplant.

FIG. 39 is a side schematic view of the implant of FIG. 38 shown in anorientation as implanted within a pelvic region.

FIG. 40 is a side perspective view of an embodiment of an implant.

FIG. 41 is a top view of another embodiment of an implant.

FIG. 42 is a side view of a portion of the implant of FIG. 41.

FIG. 43 is a side view of a portion of the implant shown in FIG. 42.

FIGS. 44-46 are each a top view of a different embodiment of an implant.

FIG. 47 is a top view of another embodiment of an implant.

FIG. 48 is a side perspective view of the implant of FIG. 47 shown in anorientation as implanted within a pelvic region.

FIG. 49 is a side perspective view of the implant of FIG. 47 shownpartially disposed within a schematic illustration of a portion of apelvic region.

FIGS. 50-52 are each a top view of a different embodiment of an implant.

FIG. 53 is a top view of an implant coupled to a dilator device.

FIG. 54 is a perspective view of the implant of FIG. 52 shown partiallydisposed within a schematic illustration of a portion of a pelvicregion.

FIG. 55 is a side perspective view of four dilator devices and theimplants of FIGS. 11 and 52 shown disposed within a schematicillustration of a portion of a pelvic region.

FIG. 56 is a top view of another embodiment of an implant shownunassembled.

FIGS. 57 and 58 are each a top view of a different embodiment of asleeve assembly.

FIG. 59 is a top view of an embodiment of an implant.

FIG. 60 is a top view of an other embodiment of an implant.

FIG. 61 is a side perspective view of a portion of a pelvic region andthe implant of FIG. 60 disposed within the pelvic region.

FIG. 62 is a side perspective view of a portion of a pelvic region andthe implant of FIG. 60 disposed within the pelvic region.

FIG. 63 is a side perspective view of a portion of a pelvic region andthe implant of FIG. 38 shown disposed within the pelvic region.

FIG. 64 is a side perspective view of a portion of a pelvic region andthe implant of FIG. 51 shown disposed within the pelvic region.

FIG. 65 is a side perspective view of a portion of an implant accordingto another embodiment of the invention.

FIGS. 66A-66D illustrate an example of an anterior incision procedure.

FIGS. 67A-67F illustrate an example of a posterior incision procedure.

DETAILED DESCRIPTION

The devices and methods described herein are generally directed toimplants (e.g., posterior support implants, anterior support implants,total pelvic floor repair implants) and the delivery and placement ofsuch implants within a pelvic region (also referred to herein as“pelvis”) of a patient. An implant can be placed into the pelvic spaceof a patient and secured at several different locations within thepelvic space to treat many different female pelvic floor dysfunctions.For example, an implant can be secured to a sacrospinous ligament or aureterosacral ligament for uterine preservation (e.g., if a prolapseduterus is otherwise healthy, a hysterectomy is not preformed and theuterus is re-suspended with an implant), or for posterior support. Inanother embodiment, an implant can be secured to pubo-urethral tissue oran obturator muscle (e.g., internus or externus) or membrane (each alsoreferred to herein as “obturator”) to treat, for example, incontinence.In yet another embodiment, an implant can be secured to a sacrospinousligament or an arcus tendineus fascia pelvis (i.e., white line) (alsoreferred to herein as “arcus tendineus”) for paravaginal repairsincluding, for example, cystoceles, rectoceles and enteroceles. Animplant can also be secured to various combinations of such locations. Asingle implant or multiple implants can be used in a single procedure.In some applications, when multiple implants are used, support can beprovided in desired areas and improved control of the direction ofstretch or support of the implant can be achieved. Various deliverydevices, delivery aids, and methods are also described for deliveringand securing an implant assembly within the patient.

An implant according to an embodiment of the invention can include oneor more tanged portion and/or one or more detanged portion. The terms“tanged” or “tangs” as used herein mean roughened or jagged edges orareas, such as can result from cutting a woven or knit mesh material.The tanged portion can be used, for example, to anchor or secure theimplant to tissue. An implant according to an embodiment of theinvention can be implanted, for example, through a vaginal incision, ina retro-pubic direction (behind the pubic bone), or in a pre-pubicdirection (in front of the pubic bone). In other embodiments, an implantcan be placed in the direction of other anatomical structures asdesired. A procedure to deploy a pelvic implant can include a singlevaginal incision, such as an anterior vaginal incision and/or ananterior vaginal incision and a posterior vaginal incision. In someembodiments, a procedure may include an exterior incision.

Various embodiments of implants are described herein. An implant can bedelivered to a pelvic region of a patient using a variety of differentdelivery devices, only some examples of which are described herein.Various delivery aids are also described, some of which can be includedas part of an implant (e.g., provided to a physician assembled) some ofwhich can be assembled to an implant just prior to implantation. Suchdelivery aids are typically removed after placing one or more straps ofan implant at a desired tissue securement location, leaving the strap toengage the tissue and support the support portion of the implant. Forexample, a sleeve or dilator assembly can be used to lead an implant ora strap of an implant through a tissue in an intracorporeal location(i.e., within the patient's body), such as the sacrospinous ligament orarcus tendineus. In other embodiments, a sleeve or dilator assembly canbe used to lead an implant or a strap of an implant through a tissue andto an extracorporeal location (outside the patient's body), such asthrough an obturator membrane or muscle and out through an exteriorincision in the patient.

In some embodiments, an implant can be associated to delivery aid, suchas a sleeve assembly or dilator device, after such delivery aid has beenplaced within a pelvic region. For example, in an embodiment of animplant having multiple straps, prior placement of a delivery aid canhelp with coordinating and organizing the placement of the variousstraps. Placing a delivery aid within a pelvic region first also helpsreduce handling of the implant which can reduce damage to the implantduring an implantation procedure.

In one embodiment, an apparatus includes a support portion disposablewithin a pelvic region and a strap extending from the support portion.The strap has a length and is configured to be disposed at leastpartially within a pelvic tissue. A sleeve is releasably disposed overat least a portion of the strap. The sleeve has a length that is longerthan the length of the strap. In some embodiments, the length of thesleeve is at least twice as long as the length of the strap. In someembodiments, a suture couples the sleeve to the strap. The suture can beat least partially disposed within an interior of the sleeve and formtwo strands of suture within the interior of the sleeve. The two strandscan be separated by a distance defined by a separator portion of thesleeve.

In another embodiment, an apparatus includes a support memberimplantable within a pelvic region and a strap that extends from thesupport member. The strap is configured to be secured within a pelvictissue to support the support member within the pelvic region. A sleeveis releasably disposed over at least a portion of the strap, and has afirst wall and a second wall defining an interior space. A suture iscoupled to the strap and coupled to the sleeve. The suture is disposedat least partially within the interior space of the sleeve and forms twostrands of suture within the interior space of the sleeve. The twostrands being separated by a distance defined by a separator portion ofthe sleeve.

In another embodiment, an apparatus includes a support memberimplantable within a pelvic region. A first strap extends from thesupport member and is configured to be secured to an arcus tendineuswhen the support member is implanted within the pelvic region. A secondstrap extends from the support member distal of the first strap and isconfigured to be secured to a sacrospinous ligament when the supportmember is implanted within a pelvic region. The first strap has a lengthsuch that the first strap can be secured to the arcus tendineus butcannot extend to a vagina after being secured to the arcus tendineus.The second strap has a length such that the second strap can be securedto the sacrospinous ligament, but cannot extend to the vagina afterbeing secured to the sacrospinous ligament. The first strap and thesecond strap configured to help support the support member at leastpartially beneath the bladder neck when the first strap is secured tothe arcus tendineus and the second strap is secured to the sacrospinousligament.

In another embodiment, a method includes inserting a pelvic implantthrough an anterior vaginal incision and into a pelvic region. Thepelvic implant includes a support portion, a strap extending from thesupport portion, and a sleeve disposed over the strap. The sleeve has alength greater than a length of the strap. The sleeve and strap arepulled at least partially through a pelvic tissue such that a firstportion of the sleeve is disposed within the pelvic tissue and a secondportion of the sleeve extends through the vaginal incision and the strapis disposed at least partially within the pelvic tissue but does notextend through the vaginal incision. The sleeve is removed from thestrap, leaving the strap at least partially disposed within the pelvictissue.

In another embodiment, a method includes inserting an implant through avaginal incision and into a pelvic region. The implant includes a firststrap and a second strap extending from a support portion. The firststrap is placed through a sacrospinous ligament of a first side of thepelvic region. The second strap is placed through an arcus tendineus ofthe first side of the pelvic region. An anterior portion of the supportportion is secured to at least one of an obturator or the arcustendineus of the first side of the pelvic region.

In another embodiment, a method includes providing a pelvic implanthaving a strap extending from a support portion of the implant. Thestrap has a first length. A portion of the support portion of theimplant is cut such that the strap has a second length greater than thefirst length of the strap. After cutting the support portion, at least aportion of the strap is placed through a pelvic tissue to at leastpartially secure the implant within a pelvic region of a patient.

As used herein, the terms proximal portion or proximal end refer to theportion or end, respectively, of a device that is closest to a physicianwhen performing a medical procedure, and the terms distal portion ordistal end refer to the portion or end, respectively, of the device thatis furthest from the physician during a medical procedure. For example,a distal end or portion of a sleeve assembly or dilator device asdescribed herein refers to the end or portion of the device that isfirst inserted into a body of a patient during a medical procedure. Theproximal end or portion is the end or portion of the device that isinserted into a body of the patient after the distal end or portion. Theterms “trailing end” and “leading end” are also referred to herein andhave similar meanings as proximal and distal, respectively. As usedherein, the term “leading end” refers to the end of a device orapparatus that is inserted into a body first. The term “trailing end”refers to the end of the device or apparatus that is inserted into thebody after the leading end.

FIG. 1 is a schematic illustration of an implant according to anembodiment of the invention. The implant 20 can be used, for example, totreat various conditions, including, but not limited to anteriorrepairs, posterior repairs, total repair, each with or without apicalrepair, or a combination thereof. An implant 20 can include a supportportion 22, and one or more straps 24. The support portion 22 can be avariety of different shapes, sizes and configurations depending on theintended use for the particular implant. For example, in someembodiments, the support portion 22 can be substantially rectangular,square, oval, or elliptical. The support portion 22 can be shaped andsized to support a bladder (e.g., to treat a cystocele) and/or a bladderneck and/or support a uterus (e.g., to treat a hysterocele) and/or tosupport a rectum (e.g. to treat a rectocele). The support portion 22 caninclude, for example, a posterior support portion and/or an anteriorsupport portion. The support portion has a length L and a width W. Insome embodiments, the length L can be, for example, between 12.6 cm(4.96 inches) to 27.69 cm (10.90 inches), and the width W can be, forexample, between 4.27 cm (1.68 inches) to 8.31 cm (3.27 inches).

The support portion 22 and/or the straps 24 can each be formed with amesh material to allow tissue in-growth to the implant 20 afterimplantation. For example, some or all of the implant 20 can be formedwith a mesh material as described in U.S. Patent Pub. 2005/0038452 A1 toChu, the disclosure of which is hereby incorporated by reference in itsentirety. In some embodiments, some or all of an implant 20 can beformed with the Advantage® Mesh or the Polyform™ Synthetic Mesh materialeach provided by Boston Scientific Corporation (“BSC”). The implant 20can be monolithically formed or alternatively, the implant 20 can beformed with multiple different materials and/or can include multipledifferent components or portions coupled together. In some embodiments,an implant 20 can be formed with a combination of materials includingsynthetic and biological materials. For example, the support portion 22can be formed with a first biocompatible material and the straps 24 canbe formed with a second biocompatible material different than the firstmaterial. In another example, the support portion 22 can be formed witha biological material, and the straps can be formed with a syntheticmaterial. The straps 24 and support portion 22 can also have a differentweave, pitch, texture, color, and pattern from each other.

The straps 24 can be formed monolithically with the support portion 22or be a separate component coupled to the support portion 22. A strap 24and support portion 22 can be coupled in an abutting relationship, anoverlapping relationship, or can be bridged. The straps 24 can becoupled to the support portion 22 by, for example, heat bonding, gluing,using fasteners, and/or sewing. In some embodiments, a strap 24 caninclude a heat seal along its length or a portion of its length toprevent or reduce stretch.

In some embodiments the support portion 22 and/or straps 24 include oneor more tanged portions (as described above). The tangs allow theimplant 20 to be anchored within pelvic tissue without the use ofadditional anchoring mechanisms or sutures. In some embodiments, animplant 20 includes tangs on an edge along an entire length of theimplant 20. In other embodiments, the implant 20 includes tangs coveringsubstantially all of an exterior surface of the implant. In someembodiments, tangs are only on the straps 24 of the implant 20. Forexample, in some embodiments the straps 24 include a tanged portion toengage and help secure the implant to pelvic tissue. Pelvic tissue caninclude, for example, ligaments, muscle (such as an obturator internusmuscle or an obturator externus muscle), fascia, or any other structureor tissue within a pelvic region of a patient.

As with the support portion 22, the straps 24 can have a variety ofdifferent configurations and/or different sizes (e.g. lengths, widths),depending on the intended use for the particular implant and theintended implantation site for the straps within the pelvic region. Forexample, straps 24 can have a length to accommodate securing the strap24 to specific anatomical location within the pelvic region, such as asacrospinous ligament, an arcus tendineus, a levator muscle, etc. Insome embodiments, an implant for use in supporting a bladder neckincludes straps that are secured to the arcus tendineus. Such straps aretypically relatively short in length, as the distance from the placementof the implant to the arcus tendineus does not require a long strap.

The length of a particular strap 24 can depend on the particular tissue(e.g., ligament, muscle) that the strap 24 is intended to be secured to,such that trimming of the strap 24 during or after placement can bereduced or eliminated. For example, in some embodiments, a strap 24 thatis configured to be secured to an anterior area of a pelvis, can have alength of about 15 cm (5.9 inches). Such a length is sufficiently longto secure the strap 24, to, for example, an arcus tendineus, but is tooshort to extend through an exterior incision in the patient (e.g., whenthe support portion is properly placed in the pelvic region of thepatient). In other embodiments, an anterior strap can have a length suchthat the strap can be passed through tissue leading towards an obturatorforamen, but not long enough to pass through the obturator foramen. Alength of an anterior strap, together with a width of the anteriorportion of the support portion 22 can be, for example, between about 5cm (2 inches) and 30 cm (12 inches). In some embodiments, a lengthmeasured from a center line of the support portion 22 to an end of thestrap can be about 7.5 cm (3.0 inches). A posterior strap 24 can have alength, for example, such that the strap 24 can be placed through, orsecured to, tissue, such as a sacrospinous ligament, but is not longenough to return back through a vaginal insertion point. In someembodiments, a strap 24 can have a length such that it can extend from apelvic region through an exterior incision of the patient. In suchembodiments, a sleeve 26 can provide an extracorporeal means to releasea strap from the sleeve 26 and obviate intracorporeal strap trimming.

The implant 20 can also include one or more sleeve members 26 (alsoreferred to as a “sleeves”) each coupled to one or more of the straps24. For example, a sleeve member 26 can be coupled to the strap 24 via asuture (not shown in FIG. 1), with a heat seal (not shown in FIG. 1), orother attachment methods, such as with fasteners or adhesive. The sleevemember 26 can be used during the insertion of the implant into a pelvicregion to prevent the straps 24 from prematurely engaging tissue duringthe delivery procedure. For example, if a strap 24 includes a tangedportion, a sleeve member 26 can prevent the tangs from engaging tissueas the implant is being delivered into the pelvic region. Conversely,when no sleeve 26 is disposed on a strap 24 having tanged edges, thetangs can engage the surrounding tissue making it difficult to smoothlyslide the strap 24 for adjustment. A sleeve 26 can also help in aprocess to adjust the tension of a strap 24, for example, to relievestrap tension.

The sleeves 26 can also protect the straps 24 from damage duringdelivery. The sleeves 26 can have a reduced profile at a distal endportion, enabling it to more easily travel through the tissue duringdelivery. For example, a sleeve 26 can be tapered. The same type orconfiguration of sleeve 26 can be disposed over each strap 24 of animplant 20, or a different type of sleeve 26 can be disposed over eachstrap 24 of an implant 20. In some embodiments, there is no sleeve 26,or a sleeve 26 is disposed over only one or some of the straps 24. Thesleeve 26 can be transparent, semi-transparent, colored, non-colored, ora combination thereof. The sleeve 26 can be, for example, tapered, flat,and/or tubular. A sleeve 20 can be formed for example, with a clear,thin, flexible biocompatible polymer, and be configured to allow theuser to examine or view the implant 20 (e.g., straps) disposed withinthe sleeve 26. After the straps 24 are positioned at a desired locationwithin the pelvic region, the sleeves 26 can be removed from the implant20, as described in more detail below. Although the sleeves 26 aredescribed herein as being part of a sleeve assembly or dilator assembly,it should be understood that a sleeve 26 can alternatively beindividually coupled to a strap.

As stated previously, an implant 20 can have any number of straps 24depending on the particular intended use for the implant 20. Forexample, an implant 20 can have between one and twenty straps 24. Insome embodiments, one or more straps 24 can extend from the supportportion 22 (e.g., a posterior support portion or an anterior supportportion) at an angle. Such an angle of a strap 24 can vary in differentembodiments, for example between 20 to 160 degrees from a centerline ofthe support portion 22.

In some embodiments, the straps 24 are configured to be secured totissue by an interference fit or frictional fit with the surroundingtissue. For example, the strap 24 can be pulled through a pelvic tissueusing, for example, a sleeve or dilator (as described herein) that isconfigured to dilate or expand the tissue and provide a lead-in (e.g.,passageway) for the strap to be pulled through the tissue. The pelvictissue is dilated such that the strap can be pulled through the tissue,but then prolapses or retracts to a smaller size to provide a frictionalinteraction between the tissue and the strap. The strap can also beflexible such that even if a width of the strap 24 is greater than awidth of a corresponding passage in the tissue formed by the lead-indevice (e.g., dilator or sleeve), the strap can flex to be pulledthrough the tissue, and the tissue can dilate or expand to receive thestrap 24. In some embodiments one or more straps 24 are tapered towardtheir distal end, and are larger in width near the support portion 22,which further provides a lead-in through the tissue.

In some embodiments, one or more of the straps 24 are substantially thesame length as their corresponding sleeves 26. In other embodiments, oneor more straps 24 are shorter than their corresponding sleeves 26. Insuch an embodiment, the sleeve can be used to provide an extension tothe strap to help in the insertion process. By forming the strap 24 witha length just sufficient to be secured to a target tissue site, theimplant 20 can be formed with less material. For example, in many cases,as mentioned above, a strap may need to be trimmed after placement in apelvis region, and the trimmed material is then discarded. The use of astrap 24 having a length configured for the particular use can thuseliminate the need for trimming and also reduce the costs to manufacturethe implant 20. Such embodiments of a strap 24 can also help preventstrap stretch that can occur during insertion of the implant due topulling on a longer length strap. A strap 24 having a length shorterthan a corresponding sleeve 26 can also help maintain the cleanliness ofa strap 24 during insertion as a substantial portion of the strap 24that will be secured within the pelvis will be protected within thesleeve 26. A strap 24 having a shorter length than its correspondingsleeve 26 can also reduce friction between the strap 24 and an interiorsurface of the sleeve 26 (due to reduced surface area contact), allowingeasier, removal of the sleeve 26.

As stated above, the support portion 22 and straps 24 can be separatecomponents. In some embodiments, a sleeve and strap assembly is providedthat is configured to be coupled to a support portion of an implant. Forexample, a support portion and one or more sleeve and strap assembly canbe provided to a user (e.g., a physician) unassembled. The user can thensecure one or more of the sleeve and strap assemblies to the supportportion to form the implant. Such embodiments are described in moredetail below.

As shown in FIG. 1, a dilator 28 can also be coupled to the sleeve 26and used to assist in the delivery of the implant 20 to the pelvicregion. A proximal end portion (or trailing end) of a dilator 28 can becoupled to a sleeve 26, for example, by crimping, knotting, heatbonding, heat sealing, stitching, stretching, or tipping or acombination thereof. In some embodiments, the sleeve 26 is formedmonolithically with the dilator 28. The dilator 28 can produce a largerpassage through tissue to facilitate strap placement. Using a dilator 28to introduce a strap 24 into a pelvic region can reduce handling orpulling of the implant 20 itself, thereby reducing or eliminatingpotential damage to the implant 20.

The dilator 28 can be a variety of different configurations. Forexample, the dilator 28 can be a variety of different lengths, shapes,diameters, etc. The dilator 28 can expand a passage formed by a trocarneedle 32 (as described below) during insertion through a tissue, toease the transition of the opening of the tissue to a cross-section ofthe sleeve 26. The sleeve 26 can also be tapered, which helps provide alead-in through or dilation of the tissue. The dilator 28 can beflexible, semi rigid, or rigid. The dilator 28 can be curved orsubstantially linear. In some embodiments, the dilator 28 is tubularshaped. For example, the dilator device 28 can define a lumentherethrough. The dilator 28 can also be tapered from a larger diameterat a proximal or trailing end to a smaller diameter at a distal orleading end of the dilator 28. The dilator 28 can also be color-coded.For example, when an implant 20 having multiple straps 24 is to bedelivered to a pelvic region, dilators 28 each having a unique color toindicate where that strap 24 is to be placed within a pelvis can becoupled to each strap. Such color-coding can help with the organizationof the delivery process. For example, in one embodiment, a pair ofanterior straps can be coupled to dilators that are blue and a pair ofposterior straps can be coupled to dilators that are white. In someembodiments, additional coding of the dilators can be included tofurther help organize the straps. For example, a pair of dilatorscoupled to anterior straps can be blue colored and one of the dilatorscan further be striped (e.g., blue and white) to help differentiatebetween the right and left side of the pelvic region to which the strapis to be secured. In some embodiments, the sleeves 26 associated withthe straps 24 can be color-coded in a similar manner as described forthe dilators 28. In some embodiments, both the sleeves 26 and thedilators 28 are color-coded.

In some embodiments, a leader 30 is coupled to a distal end of thedilator 28 and/or sleeve 26, and a trocar needle 32 is coupled to adistal end of the leader 30. The leader 30 can be a suture, formed, forexample, with a polymer. In other embodiments, the leader 30 can be madefrom metal or other fiber and can be attached at one or more locationsof a sleeve 26 and/or dilator 28. For example, the leader 30 can becoupled to the dilator 30 and/or sleeve 26 by, for example, gluing,thermo-bonding, knotting or other methods of attachment. In someembodiments, the leader 30 can be a portion of (or formed monolithicallywith) a suture used to couple the sleeve 26 to a strap 24. Although onlyone leader 30 and trocar needle 32 are illustrated in FIG. 1, it shouldbe understood that a leader 30 and trocar needle 32 can be coupled toeach of the dilators 28 and/or sleeves 26 of an implant 20.

The trocar needle 32 can be formed with various biocompatible materials,such as, for example, stainless steel, or other surgical steel. Thetrocar needle 32 can be used to associate the a strap of the implant toa delivery device, such as, for example, a Capio® Suture Capture Devicemanufactured by Boston Scientific Corporation (also referred to hereinas “BSC”). An example of such a suturing device is also described inU.S. Pat. No. 5,741,277, the disclosure of which is hereby incorporatedby reference in its entirety. Other types of delivery devices canalternatively be used, such as, for example, the suturing devicedescribed in U.S. Patent Pub. 2004/0181243 A1 to Chu et al., entitledRe-shapeable Medical Device, the disclosure of which is herebyincorporated by reference in its entirety. A similar delivery device isalso described below with reference to FIG. 7.

A length of the leader 30 (measured from a distal end of the dilator 28)can vary. For example, in some embodiments, a length of a leader 30 issufficiently long to be placed through a selected tissue anchoring site(after entering the pelvic region via a vaginal incision), and passedout through the vaginal incision, without requiring the dilator 28 toenter the vagina (e.g., after passing through a tissue within thepelvis). In some embodiments, a length of the leader 30 can allow thephysician to remove the trocar needle 32 from a delivery device externalto the body before an attached dilator 28 is pulled into the tissue orligament. More details on the insertion and delivery of an implant usinga delivery device is described below with reference to specificembodiments.

In other embodiments, rather than a leader 30 and trocar 32, the dilator28 or sleeve 26 can include a connector portion that can be used toassociate the straps 24 to a delivery device. For example, the dilator28 or sleeve 26 can include a connector portion (not shown), or aseparate connector (not shown) can be coupled to the dilator 28 orsleeve 26 that can be used to associate the strap 24 to a deliverydevice. In some embodiments, a loop connector is coupled to the sleeve26 or dilator 28. Such a connector or connector portion can be used toassociate the dilator 28 or sleeve 26 to a delivery device, such as, forexample, an Obtryx® Halo, Curve, Advantage® or Lynx® device eachmanufactured by Boston Scientific Corporation. An example of such adevice is also described in U.S. Patent Pub. No. 2005/0075660 and U.S.Patent Pub. No. 2005/0177022, the entire disclosures of which are herebyincorporated by reference in their entirety. Such a delivery device cancreate a path or passageway through, for example, an obturator muscle ormembrane (e.g., using a transobturator approach) or through, forexample, an arcus tendineus (e.g., using a transglutual approach). Forexample, the needle of the delivery device can be passed through anexterior incision and into the vagina, where it can be coupled to astrap of an implant assembly 20 (as described in more detail herein).The delivery device can be used to draw a strap or portion of theimplant 20 through a passageway formed by the delivery device andthrough the exterior entry site in an inside-out approach. An example ofsuch a delivery device is also described herein with reference to FIG.11. A dilator can also be configured to be associated to other types ofdelivery devices, such as, for example, a delivery device as describedin U.S. Provisional Application No. 60/981,159 filed Oct. 19, 2007,entitled “Apparatus For Placing Medical Implants,” the disclosure ofwhich is hereby incorporated by reference in its entirety.

The implant 20 can also be configured to be associated to other deliverydevices not specifically shown herein. In some embodiments, a strap 24of the implant 20 itself is configured to be associated to a deliverydevice. For example, a connector can be coupled directly to a strap 24for association to a delivery device, or the strap can include, forexample, an opening or hole configured to associate the strap 24 to adelivery device. In some embodiments, a leader 30 and trocar 32 can becoupled directly to a strap 24.

Delivery devices as described above can be used to deliver selectedstraps of the implant 20 to or through a pelvic tissue, such as, forexample, a levator muscle (e.g., levator ani muscle), a sacrospinousligament, a tendineus arch of levator muscle (also referred to herein as“arcus tendineus” or “white line”), obturator muscles, or to aniliococcygeus muscle, or to other anatomical securement sites within thepelvic region of a patient. The delivery device can also be used to passa suture end through a wall of a vagina or to pass a suture through theepithelium of a vaginal wall without passing the suture through thevaginal wall. For example, straps 24 of the implant 20 can be depositedat selected tissue sites within the pelvic region and a portion of animplant 20 can also be coupled to a vagina of the patient, such as tothe vaginal apex, to a wall of the vagina, secured inside the vagina(e.g., within a vaginal lumen) or within the pelvic region.

In some embodiments, only one implant 20 is implanted within a pelvicregion. In other embodiments, more than one implant 20 are implanted.For example, a first implant can be placed posteriorly and be secured toa sacrospinous ligament, and a second implant can be placed anteriorlyand secured to an arcus tendineus to support, for example, a bladderneck of a patient. In another example, a first implant can be secured onone side of a pelvic region of a patient, and a second implant can besecured on a contra lateral side of the pelvic region. In someembodiments, the implant 20 is sized to extend from a posterior regionto an anterior region of a pelvic region of a patient. In yet otherembodiments, the implant 20 is sized to extend from one side of thepelvic region to the other side of the pelvic region, or to span asubstantial portion of the pelvic floor, such as in total pelvic floorrepair implants.

The implant 20 can be used in its entirety, or alternatively, theimplant 20 can be split into two or more portions. For example, animplant 20 can be cut into two portions, such as a posterior portion andan anterior portion. Each portion can then be used to treat a specificprolapse condition. In some embodiments, an implant 20 can be trimmed inwidth W and/or length L, before or during placement, to accommodate fordifferent-sized pelvic regions. Thus, an implant 20 can be modified orcustomized by the user, for example by cutting. In other embodiments, animplant 20 can have more than two support portions. For example, animplant 20 can include multiple support portions 22 that are spaced at adistance from each other.

An implant 20 can be delivered or implanted into a pelvic region using avariety of different approaches, including for example, a transvaginalapproach, a retropubic approach (e.g., the implant is placed through avaginal incision and the anterior straps of the implant (see e.g.,anterior straps 134 in FIG. 2) can then be placed by a supra pubicapproach, or a transobturator approach). In one example, an implant 20can be delivered using a transvaginal approach using for example, aCapio® device as described above. In such a procedure, the implant 20 isinserted through, for example, a single vaginal incision. The anteriorstraps of implant 20 can alternatively be implanted using atransobturator approach, using, for example, a delivery needle, such asan Obtryx® Curve or Obtryx® Halo as described above. In such aprocedure, the implant 20 is inserted through a mid-line incision,through an obturator foramen and to a exterior incision. Such proceduresare described in more detail below with reference to specificembodiments. An implant 20 (e.g., an incontinence implant having twostraps) can alternatively be implanted using only a transobturatorapproach, using, for example, a delivery needle, such as an Obtryx®Curve or Halo as described above. In such a procedure, the implant 20 isinserted through a mid-line incision, through an obturator foramen andto an exterior incision. Such procedures are described in more detailbelow with reference to specific embodiments. In other procedures, theimplant 20 is inserted through a mid-line incision, through an obturatorforamen, but does not exit the skin.

Although the above-described embodiments describe securing a strap 24 totissue without the use of a separate anchoring device (for example,securing with tangs of a strap), it should be understood that theimplants described herein can also include anchors or other mechanicalfasteners to secure one or more straps 24 to the pelvic tissue. Forexample, a suture can be used to secure a strap or other portion of animplant 20 to tissue, such as to a vaginal cuff. For example, thesupport portion 22 can be secured with a suture to a vaginal cuff forapical suspension. In another embodiment, an incontinence sling, orother types of pelvic floor implant can be used in conjunction with animplant 20.

Having described above various general principles, several exemplaryembodiments of these concepts are now described. These embodiments areonly examples, and many other configurations of an implant, sleeveassembly, or dilator assembly, etc., are contemplated.

FIGS. 2-6 illustrate an example of an embodiment of an implant. Animplant 120 includes six straps, including two anterior straps 134, twomid straps 136, and two posterior straps 138. The implant 120 alsoincludes a support portion 122 having an anterior support portion 144between the anterior straps 134 and the mid straps 136, and a posteriorsupport portion 146 extending between an end 125 of the implant 120 andthe posterior straps 138. A center marking 139 is included along acenterline of the support portion 122 that can be used to help positionthe implant 120 in a desired location within a pelvic region of apatient.

In this embodiment, a length of each of the straps 134, 136, 138 issufficient to secure the strap to its intended tissue securement site,but not long enough that the straps extend out of the vagina duringdelivery of the implant into the pelvic region using, for example, atransvaginal approach. Such a length of the straps eliminates or reducesthe need for trimming large portions of the straps after placement andcan also reduce clutter in the vagina and/or pelvic region duringplacement of the implant 120.

As best shown in FIGS. 3-5, the anterior straps 134 can also includetextured surfaces. Specifically, in the illustrated embodiment thestraps 134 include dimples 140 on a top and bottom surface of theanterior straps 134. As shown in FIG. 5, the dimples 140 are disposed inalternating, opposed directions on the top and bottom surfaces of thestrap 134. The dimples 140 provide added gripping strength to engagesurrounding tissue. The number of dimples 140 can vary and can also beincluded on other straps of the implant 120 and/or some or all of thesupport portion 122. The straps 134, 136, 138 can also include tangs asdescribed above and/or can include barbs or other protrusions configuredto engage tissue.

The dimples 140 can be tapered from their base to an end of the dimple140. For example, the dimples 140 can be dome-shaped having a largerdiameter at their base than a diameter at their tip or end. The dimples140 can have a width (e.g., a diameter), for example, between about 0.02cm (0.008 inches) and 0.04 cm (0.02 inches) at their tip and/or at theirbase. For example, a width of a dimple 140 can be about 0.36 cm (0.14inches) at its base and narrow or taper to about 0.22 cm (0.087 inches)at an end or tip. Dimples 140 can have a length or height, for example,between about 0.15 cm (0.059 inches) and 0.23 cm (0.091 inches) and canbe spaced apart from each other (e.g., from a centerline of one dimpleto a center line of an other dimple) about 0.6 cm (0.2 inches). In someembodiments, dimples 140 can also be positioned such that they contactone another, overlap or are spaced at different distances from eachother. In other embodiments, the dimples 140 may not be tapered.

The straps can include, for example, between 1 and 1000 dimples. Dimples140 can be provided on any of the straps (134, 136, 138) and/or thesupport portions (144, 146) of an implant. Dimples 140 can be formedthrough heat stamping of the strap material. In other embodiments,dimples 140 or other surface textures can be created through othermethods such as, for example, stamping, extruding, molding, or weaving.

A sleeve assembly 154 including a sleeve 126 and a tapered dilator 128is disposed over each of the straps 134, 136, and 138 (shown in FIG. 2only). The dilators 128 can be coupled to the sleeve 126 by, forexample, crimping, heat sealing, stitching, stretching, tip tipping,etc. Alternatively, the sleeve 126 can be formed to include a portionthat forms a tapered dilator. The dilator 128 can be used to expand orenlarge a passage during insertion through a tissue, to ease thetransition to a cross-section or size of the sleeve 126. The sleeve 126is also tapered, which also helps provide a lead-in through the tissue.

The sleeves 126 are secured to the straps with sutures 142. A suture 142is looped through each of the straps 134, 136 and 138. In thisembodiment, the sutures 142 are weaved or threaded through the straps134, 136 and 138. For example, as shown in FIG. 6, the suture 142 isweaved through the strap 134 implant 120 at location A. Such a couplingof the suture 142 threaded through the straps 134, 136 and 138 can alsohelp prevent strap stretch. The sutures 142 can alternatively be coupledto the straps 134, 136 and 138 using, for example, any of the methodsdescribed above for the dilator to sleeve coupling, for example, bycrimping, heat sealing, stitching, stretching, tip tipping, etc. In someembodiments, a suture can be threaded to or secured to a strap, forexample by knotting. The strands of the sutures 142 forming the loopthrough the sleeves 126 extend through an interior lumen (not shown) ofthe dilators 128 and are crimped closed and heat bonded to an interiorwall of the dilators 128 at, for example, a location B shown in FIG. 6,to maintain the straps 134, 136 and 138 within the sleeves 126.

A leader suture 130 is coupled to and extends distally from each of thedilators 128. Alternatively, a leader portion of the sutures 142 canextend distally from the dilators 128. A trocar needle 132 is coupled toa distal end of each of the leader sutures 130. As described previously,the trocar needles 132 can be used to associate the implant 120 to adelivery device, such as a BSC Capio® device described above or adelivery device 164 described below.

The sleeves 126 each include a separator 148 disposed between twostrands of the looped suture 142 and near a distal end of the sleeve126, as best viewed in FIG. 6. The separator 148 maintains separation ofthe strands of the looped suture 142 within the sleeve 126. Theseparation of the strands of the suture 142 enable or help facilitate acut to be made through only a single strand of the looped suture 142 at,for example, location C or D, during removal of the sleeve 126, asdescribed in more detail below. In this embodiment, the separator 148 isa circular seal configuration, which can be formed, for example, by heatstamping two sides of the sleeve 126 together (or the use of tacksdescribed below with reference to FIG. 65). Other types of separatorscan alternatively be used, such as for example, a separate componentcoupled within the sleeve 126, or an adhesive can be used to couple thetwo sides of the sleeve 126 together at a location between the strands.

The dilators 128 taper from a first diameter at a trailing end 150 to asecond, smaller diameter at a leading end 152 (see FIG. 6). The firstdiameter can be, for example, between about 0.2 and 0.5 cm (0.08 to 0.2inches) and the second diameter can be, for example, between about 0.03to 0.2 cm (0.01 to 0.08 inches). For example, in some embodiments, thefirst diameter can be about 0.37 cm (0.15 inches) and the correspondingsecond diameter can be, 0.03 cm (0.01 inches). The dilators 128 can beformed, for example, by molding, extruding, casting, sintering, forging,machining, or other known methods of manufacturing such medical devices.

The implant 120 can be delivered into a pelvic region through a vaginalincision (e.g., a transvaginal approach). An incision can be made, forexample, along an anterior vaginal mucosa. The incision can be, forexample, 4 cm to 6 cm (1.57 to 2.36 inches) in length and can extendapproximately 2 cm to 3 cm (0.79 inches to 1.18 inches) to the meatus.The vaginal epithelium is dissected from the underlying periurethralfascia toward the sacrospinous ligament. Specifically, the anteriorvaginal wall is opened and the endopelvic connective tissue is separatedfrom the pubic ramus at the level of the bladder neck to the ischialspine, exposing the paravesical and pararectal space. The sacrospinousligament is identified and isolated through this defect. The anteriorincision to place the implant 120 is about 4 cm long extending about 1cm from the cervix to the level of the proximal urethra. The incision isalso known to be an anterior corporaphy incision. Details of such aprocedure are illustrated in FIGS. 66A-66D (described in more detailbelow). A posterior incision can also be made to gain access to placethe posterior portion of the implant 120 (e.g., if the uterus has beenremoved). A posterior incision is made at the vagina apex and at adistal portion of the vagina. A subepithellial tunnel between theincisions is dissected of the posterior vaginal wall from the anteriorrectal wall. Another type of posterior incision can also be made whereexcess tissue is excised as illustrated in FIGS. 67A-67F (described inmore detail below). In some cases, where the uterus is removed, theincision can include a single continuous incision (combining an anteriorand posterior incision). When the uterus is to be left intact, separateanterior and posterior implant and incisions can be used. Other types ofincisions can be used to gain access to a pelvic region. Variations inthe incisions can depend, for example, on the implant size, the neededrepair or disease state to be treated, and/or the location of theintended placement of the implant.

The various straps (e.g., 134, 136, 138) of the implant 120 can each bedelivered through pelvic tissue using, for example, the suturingdelivery device 164, as shown in FIG. 7. The trocar needle 132 on one ofthe straps (134, 136, 138) is loaded into the carrier 162 (shownpartially extended in FIG. 7) of the delivery device 164. The deliverydevice 164 can then be used to pass the trocar needle 132 and the strap(with the sleeve assembly attached thereto) through a pelvic tissue.Specifically, the carrier 162 of the delivery device 164 is positionedadjacent a selected tissue site and the carrier 162 is actuated suchthat the trocar needle 132 pierces through the tissue. The trocar needle132 and a distal end of the leader suture 130 are caught or retrieved bya catch 160 of the delivery device 164 after passing through the tissue.The delivery device 164 is then removed through the vagina, and thetrocar needle 132 is removed from the catch 160. The sleeve assembly 154is pulled through the tissue. For example, the user can pull the leader130 or the dilator 128 through the tissue such that the strap isdisposed within the tissue. This procedure is then repeated for othersleeve assemblies coupled to the other straps of the implant 120. Eachstrap of the implant is pulled through a selected tissue site and thestraps are adjusted to position and tension the anterior support portion144. Each strap can be delivered sequentially using the same deliverydevice, or separate delivery devices can be used for some or all of thestraps. The straps 134, 136 and 138 (with sleeve assemblies 154 stillattached) can be tensioned using visual guidance as the user observesthe positioning of the support portion 122 for the correct tensionthrough the vaginal incision.

After each strap (with sleeve assembly attached thereto) has been placedthrough a selected tissue site and adjusted as described above, thesleeve 126 and dilator 128 can be removed from the implant 120. Forexample, as shown in FIG. 6, to remove the sleeve 126 and dilator 128from strap 134, a portion of the sleeve 126 and one strand of the loopof the suture 142 within the sleeve 126 can be cut, for example, atlocation C or D. Since the strap 134 is coupled to the sleeve 126 viathe suture 142, cutting through a portion of the sleeve 126, and onestrand of the loop of the suture 142, the sleeve 126 will be freelymovable relative to the strap 134. The sleeve 126 (and dilator 128coupled to the sleeve 126) can then be pulled off of the strap 134 bypulling on the sleeve 126 and the uncut strand of the suture 142. Thecut suture 142 will also be free to pull through the strap 134. Thus,the suture 142 remains secured to the sleeve 126 and will simply unravelor unthread itself from the strap 134. With the sleeves 126 removed fromthe straps 134, 136, 138 tangs on the straps 134, 136, 138 can engagethe surrounding tissue into which the strap 134, 136, 138 has beenplaced. The dimples 140 on the straps 134 can also engage surroundingtissue.

The posterior support portion 146 can be positioned around a vaginalcuff before or after removing the sleeves 126 from the straps 134, 136,138. In some embodiments, a posterior vaginal incision is made toprovide access for positioning the posterior support portion 146. Forexample, a physician can access the posterior support portion 146 via aposterior incision and using a hand can tuck or wrap the posteriorsupport portion 146 around a vaginal cuff in a posterior region of thepelvis between the vagina and a rectum of a patient. The posteriorsupport portion 146 can also optionally be secured to tissue or ligamentwithin the pelvic region. For example, the posterior support portion canbe sutured or stitched to a rectovaginal septum or a perineal body.

As stated above, the straps (134, 136, 138) can be secured within apelvic region at various different tissue sites. For example, theanterior straps 134 of the implant 120 can be placed through, endopelvicfascia, or through tissue or ligaments near or in the pubococcygeusmuscle, puborectalis muscle, distal tendineus arch of levator ani muscleor obturator internus or externus muscle, or obturator membrane or othertissue locations within a pelvic region. The mid-straps 136 can each beplaced, for example, within a ischio-coccygeus muscle, an arcustendineus or obturator muscle or membrane. The posterior straps can beplaced, for example, in a sacrospinous ligament or coccygeus muscle.

The order in which the straps (134, 136, 138) are placed can vary. Inone example order of delivering the straps, first the posterior straps138 are delivered on each side of the pelvic region, and placed within,for example, sacrospinous ligaments. Then the mid straps 136 aredelivered and placed within an arcus tendineus, and lastly the anteriorstraps 134 are delivered and placed within either the arcus tendineus oran obturator (e.g., obturator muscle or membrane). The location of adilator 128 during the delivery process can be used to distinctivelyidentify which dilator 128 has been passed through which tissue (e.g.,arcus tendineus, obturator). For example, a location of a dilatorexiting a vaginal anterior incision relative to the vagina (e.g., alonga side, near the top, or near the bottom) can help indicate which tissuesecurement site corresponds to which dilator. For example, a dilatorextending from a side of the vagina can indicate that the dilator wasplaced through the patient's arcus tendineus.

The order of tensioning of the straps can also vary. In someembodiments, the anterior straps 134 can be tensioned first, then themid straps 136, and lastly the posterior straps 138. The anterior straps134 can be used to position the anterior support portion 144longitudinally and laterally. The mid straps 136 can be used, forexample, to adjust and position the posterior support portion 148. Theposterior straps 138 can provide a “deeper” anchor point and a properangle for vaginal support.

In some medical procedures, the implant 120 can be cut into two separateportions such as an anterior and a posterior portion. One or both of theportions can then be implanted depending on the particular conditionbeing treated. The implant 120 can also optionally be cut to form adifferent shape or size. For example, in a patient having a uterus, animplant having a posterior support portion and an anterior supportportion can be cut into two portions. The length and/or width of each ofthe straps can also be modified. For example, in some embodiments, itmay be desirable to cut off or otherwise remove one or more of thestraps. For example, a physician may elect to cut off the anteriorstraps and secure an anterior portion of the implant to pelvic fasciausing sutures.

FIG. 8 illustrates an implant 120′ that is similar to the implant 120.The implant 120′ includes only four straps, including two mid straps136′ and two posterior straps 138′. A sleeve assembly 154′ is coupled toeach of the straps 136′ and 138′. The sleeve assemblies 154′ areconstructed the same as the sleeve assemblies 154 described above. Theimplant 120′ also includes an anterior support portion 144′ and aposterior support portion 146′. In this embodiment, the anterior supportportion 144′ includes a pair of shoulders 143′ that can be anchored to atissue, such as for example, a levator muscle, an obturator, or an arcustendineus. The shoulders 143′ can be secured to such tissue, forexample, with sutures. As with the implant 120, the straps 136′, 138′can also include tangs as described above and/or can include barbs orother protrusions configured to engage tissue. The implant 120′ can beplaced through an anterior incision, the support portion 146′ can be cutoff and not used when a uterus is present. When there is no uteruspresent, the posterior support portion 146′ (and also support portion146 of implant 120) can be tucked though a posterior blunt dissectionthrough the anterior dissection or through an additional posteriorincision. The straps 136′ and 138′ can be delivered and anchored totissue in the same manner as described above for implant 120. Forexample, the posterior straps 138′ can each be secured to a sacrospinousligament (on opposite sides of a pelvis) and the mid straps 136′ caneach be secured to an arcus tendineus (on opposite sides of a pelvis).The posterior support portion 146′ can be wrapped around a vaginal cuff.For example, a physician can access the posterior area via an anterioror posterior vaginal incision to then pulled or tuck the posteriorsupport portion 146′ into a desired position.

Various components of the implants 120 and 120′ can vary as describedherein. For example, other configurations of the sleeve, dilator,suture, leader, etc. can alternatively be coupled to the straps of theimplants 120 or 120′ to aid in the delivery procedure. For example, asleeve or dilator assembly that can associate the implant 120 or implant120′ to a type of delivery device not described herein can alternativelybe used.

FIGS. 9 and 10 illustrate another embodiment of an implant that issimilar to the implant 120. In this embodiment, an implant 220 includesanterior straps 234, mid straps 236, and posterior straps 238. Theimplant 220 includes removable sleeve assemblies 254 having sleeves 226and dilators 228, disposed over the mid-straps 236 and the posteriorstraps 238. The sleeve assemblies 254 have the same configuration as thesleeve assemblies 154 and 154′ such that the straps 236 and 238 can bedelivered using a suturing device (e.g., a delivery device 164) in thesame manner as described above.

This embodiment differs from the previous embodiment in that the implant220 includes a sleeve assembly 254′ disposed over each of the anteriorstraps 234. The sleeve assemblies 254′ include a sleeve 256, dilators258 coupled to the sleeves 256, and loop connectors 266 coupled to thedilators 258. The anterior straps 234 are secured to the sleeves 256with a suture 242 in a similar manner as described above for theprevious embodiment. As best shown in FIG. 10, the sutures 242 arelooped through the straps 234 and through a portion of an anteriorsupport portion 244 at location A. The sutures 242 are secured to thesleeves 256 with a heat seal 268 applied across each of the sleeves 256.The heat seals 268 can maintain the position of the suture 242 and helpprevent the strands of the suture 242 from coming together within thesleeves 256 (e.g., keeps the strands separated from each other). Thus,an additional separator portion or member (e.g., separator 148 in theprevious embodiment) is not necessary to separate the strands of thesuture 242. The sutures 242 can be further secured to the sleeves 256 byforming a knot 270 with the suture 242 on a distal side of the heatseals 268. The knots 270 are sufficiently large to prevent migration ofthe suture 242 past the heat seals 268. In other embodiments a knot 270is not used, rather, the suture 242 is heat bonded directly to thesleeve 256 to prevent movement of the suture 242.

The anterior straps 234 can have a length, such that the straps 234 willnot exit the skin at either side of the patient when pulled through aneedle passageway as described below. When the sleeve assembly 254 andstrap 234 are pulled through a tissue, a tension force can betransferred from the sleeve 256 to the suture 242 via the heat seals268, then to the anterior support portion 244. This prevents the strap234 from stretching within the sleeve 256 and maintains a uniform strapwidth to maximize its holding strength during delivery. The heat seals268 can also help prevent the strap from inadvertently separating fromthe sleeve 256 during delivery of the strap 234 through a tissue.

The loop connector 266 can be, for example, a portion of a leader (e.g.,suture) that extends from a distal end of the dilator 266. In otherembodiments, different types and configurations of the loop connector266 can alternatively be used. The loop connector 266 can be used toassociate a strap 234 to a delivery device, such as, a delivery device264 shown in FIG. 11. The delivery device 264 can be, for example, anObtryx® Curve device, an Obtryx® Halo device, a Curve, or a Lynx® deviceall manufactured by Boston Scientific Corporation as described above.

The delivery device 264 includes a handle 272, a curved shaft or needle274, and a connector end 276. The connector end 276 defines a notch 278that is configured to receive the loop connector 264. Although thedelivery device 264 is shown having a curved needle 274, in otherembodiments, the needle is substantially straight, angled or curved at adifferent radius of curvature than as shown in FIG. 11. The deliverydevice 264 can be used, for example, to deliver the anterior straps 234of the implant 220 as described in more detail below. It should beunderstood that the delivery device 264 is merely an example of the typeof delivery device that can be used to deliver the strap 234 to adesired location within a pelvic region of a patient. For example, insome embodiments, a tube shaped connector is coupled to the distal endof the elongate body of the dilator to associate the dilator to adelivery device such as those used in the Advantage® or Prefyx™ systemsmanufactured by Boston Scientific Corporation. Such a device can beused, for example, to deliver a portion of an implant in a retro pubicor pre-pubic approach.

Using a delivery device, such as delivery device 264, the anteriorstraps 234 (with attached sleeve assemblies 254) can be passed through adesired tissue location within a pelvis. Such a procedure can includeinserting the delivery device needle 274 through an exterior incisionand then through, for example, an obturator foramen and to a mid-lineincision in a vagina using an outside-in approach. The loop connector266 of the sleeve assembly 254 is associated to the notch 278 of thedelivery device 264. The sleeve assembly 254 is then pulled back throughthe path formed by the insertion of the curved needle 274 until theneedle 274 exits the patient's body. This procedure can then be repeatedon the contra lateral side of the pelvic region. The straps 234 can betensioned using visual guidance as the user observes the positioning ofthe support portion 244 of the implant 220 through the vaginal incision.

After pulling the sleeve assembly 254 (and strap 234) through a tissue(e.g. using the delivery device 264), the sleeve assembly 254 can beremoved from the strap 234 in a similar manner as described for theprevious embodiment. For example, a portion of the sleeve 256 and astrand of the suture 242 are cut, for example, at a location C or D, asindicated in FIG. 10. The heat seal 268 maintains the strands of thesuture 242 apart from each other to facilitate cutting only one strandof the suture 242. The cut sleeve assembly 254 is then pulled in adirection of arrow E, which releases the sleeve 256 from the strap 234and allows the suture 242 to unravel or unthread from the strap 234. Thesleeve assembly 254 can alternatively be released from the strap 234 bycutting all the way through the sleeve 256 and suture 242 at, forexample location C or D. In such a case, pieces of the sleeve assembly254 and remaining portions of suture 242 can be manually removed.

After all straps (234, 236, 238) are tensioned, and the sleeveassemblies 237, 254 are removed, additional trimming of the straps maybe unnecessary due to the length of the straps as previously described.Although the procedure above described secured the anterior straps 234using an inside-out approach, the delivery device 264 (and like devices,such as, e.g. a BSC Obtryx® delivery device) can be used in an“outside-in” approach similar to the delivery device 164. For example,the delivery device can be inserted through a vaginal incision and usedto pass the strap 234 via the loop connector 266 through, a pelvictissue, such as an obturator muscle or membrane.

FIG. 12 illustrates another example of an implant. An implant 320includes anterior straps 334, mid-line straps 336, posterior straps 338,a support portion 322 that includes an anterior support portion 344 anda posterior support portion 346. The implant 320 can be used, forexample, for a cystocele repair and can be placed on an anterior side ofa vagina. Each of the straps 334, 336, 338 can be associated to variousconfigurations of sleeves, sleeve assemblies, and/or dilator devices fordelivery of the straps to a pelvic region. In this embodiment, each ofthe straps 334, 336, 338 include a grooved or recessed portion 380 thathas a smaller width than a remaining portion of the strap. The groovedportions 380 can indicate a location to associate the strap to aconnector of a dilator and/or sleeve/dilator assembly. FIG. 13illustrates four example dilator devices (also referred to as “dilator”)labeled 328 and 328′ that can be used to deliver the straps of theimplant 320. Dilators 328 are each shown passed through a schematicrepresentation of an arcus tendineus (AT). Dilator devices 328′ are eachshown passed through a schematic representation of a sacrospinousligament (SSL). The dilators 328, 328′ can be passed through the varioustissue locations, for example, using a delivery device, such as deliverydevice 164 described herein by associating a trocar needle 332, 332′ ofthe dilators 328, 328′ to the delivery device.

The straps of implant 320 are configured to be associated to dilators328, 328′ after the dilators have been placed in the patient. Forexample, the dilator devices 328, 328′ can be passed through tissue aspreviously described using a delivery device, such as delivery device164. The various straps of the implant 320 can be associated to aselected dilator 328, 328′ and then passed through the tissue using thedilator. For example, as shown in FIG. 13, the straps 336 can be placedthrough loop connectors 366 as indicated by the arrows A and D, andsecured to the dilators 328 by moving or sliding a slidable tube member331 of the dilators 328 towards and over the loop connectors 366 and theportion of the straps 336 within the loop connectors 366. The tubemembers 331 can frictionally hold the straps 336 to the loop connectors366. The straps 338 of the implant 320 can be similarly secured to thedilators 328′ by passing the straps 338 through loop connectors 366′ asindicated by the arrows B and C and sliding slidable tube members 331′.The dilators 328, 328′ can then be used to pull the respective strapsthrough the sacrospinous ligaments and the arcus tendineus as indicatedin FIG. 13. Although not shown in FIG. 13, the anterior straps 334 canbe delivered into a pelvic region and through a tissue in a similarmanner. For example, the straps 334 can be coupled to a dilator deviceand pulled through an obturator muscle or membrane using a deliverydevice, such as delivery device 164. In some embodiments, a connectorcan be coupled to the straps 334 such that the straps 334 can bedelivered using a delivery device, such as delivery device 264 shown inFIG. 11.

FIG. 14 illustrates an embodiment of an implant that is similar to theimplant 320 but the posterior support portion is extended to provide aposterior tail support. An implant 420 can be used, for example, forcystocele and rectocele repairs. The implant 420 includes anteriorstraps 434, mid-line straps 436, posterior straps 438, an anteriorsupport portion 444 and a posterior support portion 446. Although notshown in FIG. 14, the implant 420 can be formed with a mesh material,and can include sleeve assemblies, sleeves and/or dilators as describedherein to assist in the delivery of the straps to the pelvic region. Forexample, the implant 420 can be configured such that the straps 434,436, 438 of the implant 420 can be delivered using a delivery devicesuch as, for example, delivery device 164 and/or delivery device 264.

The posterior support portion 446 can be trimmed to a desired length fora customized fit. In some embodiments, the implant 420 can include amarking line (not shown in FIG. 14) along the implant to indicate whereto trim the implant. The posterior support portion 446 can be trimmed,for example, to modify the implant 420 to have a posterior supportportion substantially similar to implant 320 previously described. Suchmodification may be desired when only a cystocele repair is needed. Whenimplanted into a patient's pelvic region, the posterior tail support 446can be tucked into the posterior side of a vagina as described abovewith reference to implants 120 and 120′.

FIG. 15 is a schematic side view of the implant 420 after placementwithin a pelvic region. The point E represents the anterior strap 434secured to an obturator membrane or muscle, the point F represents themid-line straps 436 secured to an arcus tendineus, and point Grepresents the posterior straps 438 secured to a sacrospinous ligaments.The posterior support portion 446 is shown pulled in a direction ofarrow Z, to customize a vaginal wrap 441 about a vaginal cuff.

FIGS. 16-21 are each a different embodiment of an implant having fourstraps for fixation within a pelvic region. As shown in FIG. 16, animplant 520 includes anterior straps 534, posterior straps 538 and asupport portion 544. Sleeve assemblies 554 are similar to sleeveassemblies 254′ in FIG. 8 and are disposed over the straps 534. Thesleeve assemblies 554 include sleeves 526, dilators 558 and connectors566. The sleeves 526 can be made of a clear biocompatible polymer andinclude windows or openings 582. The anterior straps 534 can be coupledto the sleeves 526 by a heat seal 568. The windows 582 provide an accessport for a cutting tool, such as scissors, to access and cut the strap534, and optionally to cut at least one wall of the sleeve 526. Aspreviously described, this allows the strap 534 to detach from theheat-sealed portion of the sleeve 526 for removal of the sleeve 526after implantation of the implant 520.

As illustrated in FIG. 16, a leader suture 530 is coupled to each of theposterior straps 538 by knotting the leader suture 530 directly to theposterior strap 538. A single knot 570 or multiple knots 570′ can beused. The posterior straps 538 are tapered to provide easier insertionthrough tissue. A trocar needle 532 is coupled to a distal end of eachof the leader sutures 530. As described above, the trocar needles 532can be used to associate the implant 520 to a delivery device, such asdelivery device 164 (FIG. 7). The leader suture 530 and a portion of thestrap 538 (if needed) can be trimmed and discarded after the implant 520is placed in a desired location. In some embodiments, a substantialportion of the strap 538 can be cut off. For example, the strap 538 canbe cut at location A. The posterior straps 538 can be secured, forexample, to a sacrospinous ligament or a coccygeus muscle.

The anterior straps 534 can be placed within, for example, an arcustendineus (white line), or an obturator membrane or muscle using any ofthe various approaches described herein. For example, the anteriorstraps 534 can be placed using a transobturator approach, a transvaginalretropubic approach, a suprapubic approach, or in front of a pubic bone.A delivery device, such as delivery device 264 (FIG. 11) can be used todeliver the straps 234 via connectors 566 as described above. Tangs (notillustrated) on edges of the straps 534, 538 can engage the surroundingtissue after being implanted, as described above.

FIG. 17 illustrates an embodiment of an implant similar to the previousembodiment (implant 520), but in this embodiment the implant includesinsertion aids. An implant 620 includes a support portion 644, anteriorstraps 634 and posterior straps 638. The anterior straps 634 and sleeveassemblies 654 are constructed the same as with the implant 520. Theimplant 620 includes an insertion aid 684 coupled to each of theposterior straps 638 to protect the straps 638 from damage andelongation during placement. In this embodiment, the insertion aids 684include a dilator 658. The insertion aids 684 can be coupled to thestraps 638 with a friction fit, with sutures, gluing, bonding, etc. Theinsertion aid 684 can help prevent the implant material (e.g., mesh)from cutting through muscle or ligaments when being pulled through suchtissue during placement. The insertion aids 684 can also reduce theoverall size (e.g., footprint) of the implant. For example, as describedabove (e.g., for implants 120, 120′), a length of the straps 638 can beshorter than a length of the insertion aids 684. The insertion aids 684thus, can provide a longer effective length of the straps 638 to aid inpulling the straps 638 through tissue. A length of the insertion aids684 can also vary.

A bullet trocar needle 632 is attached to a leading end of a leadersuture 630 extending distally from each of the insertion aids 684 andcan be used to associate each of the straps 638 to a delivery device(e.g., delivery device 164) as previously described. As with theprevious embodiment (e.g., implant 520), the leader/dilator portions(630, 632, 684) and a portion of the strap 638 can be trimmed anddiscarded after the implant 620 is placed.

FIG. 18 illustrates another implant formed similar to the implant 620,but with insertion aids that include a sleeve. An implant 720 includes asupport portion 744, anterior straps 734, posterior straps 738, andsleeve assemblies 754. The anterior straps 734 and sleeve assemblies 754are constructed the same as the straps 634 and sleeve assemblies 654described above. An insertion aid 784 includes a tapered sleeve 726 thatis disposed over a portion of each of the posterior straps 738. Theinsertion aids 784 can be coupled to the posterior straps 738 with, forexample, by applying a heat seal 768 to the sleeves 726. As with theprevious embodiments, a leader suture 730 and trocar needle 732 arecoupled to the sleeves 726 and used to associate the implant 720 to adelivery device.

FIG. 19 illustrates an embodiment of an implant that is configured toabut to anchoring tissue at two points without the use of straps. Animplant 820 includes a support portion 844, anterior straps 834,posterior straps 838 and sleeve assemblies 854. The anterior straps 834and sleeve assemblies 854 are constructed the same as in the implants520, 620 and 720. In this embodiment, the implant 820 includes aposterior support portion 846 that defines a pair of curved tabs orshoulders 886. A suture 842 is coupled to each of the curved tabs 886with two nooses or loops 888 a and 888 b. The nooses 888 a and 888 b canbe formed, for example, by threading or passing the suture 842 throughthe curved tabs 886 of the posterior support portion 846 two timeswithout tightening the suture 842. A trocar needle 832 is coupled to anend of a leader portion 830 of the suture 842, and an end portion 890 ofthe suture 842 is left free.

To secure a curved tab 886 to a tissue, the trocar needle 832 is passedthrough the nooses 888 a and 888 b, and loaded onto a carrier of adelivery device (e.g., a delivery device 164). The delivery device isapproximated to an anchoring tissue, and the carrier of the deliverydevice is activated to pass the trocar needle 832 through the tissue asdescribed above for previous embodiments. The catch on the deliverydevice receives the trocar needle 832, and the delivery device isremoved from the body, passing the leader portion 830 attached to thedelivery device through the noose 888 a and the noose 888 b. The trocarneedle 832 is then removed from the catch. The procedure is thenrepeated on the contra-lateral side. The noose 888 a can be drawn closedwhen the leader portion 830 is pulled, and the noose 888 b can be drawnclosed when the end portion 890 is pulled. The leader portion 830 oneach side can be pulled intermittently to abut the implant 820 to thetissue. The leader portion 830 and the end portion 890 can be crossedand pushed in, for example, with a finger, to form a knot to secure thecurved tab 886 to the tissue.

FIG. 20 illustrates another embodiment of an implant constructed similarto the implant 520. In this embodiment, the mesh strands are orientedperpendicularly rather than in an angular pattern. An implant 920includes a support portion 944 and posterior straps 938 having a leaderportion 930 coupled thereto using, for example, an adhesive or heatbonding. As shown in FIG. 20 the mesh strands of implant 920 (e.g., thesupport portion 922 and posterior straps 938) are oriented in aperpendicular pattern. Such a configuration of the mesh strands can helpreduce strap stretch.

FIG. 21 illustrates an implant 1020 that is constructed similar to theimplant 820 in FIG. 18. As with the implant 820, the implant 1020includes a support portion 1044, posterior straps 1038 and insertionaids 1084 that include sleeves 1026. In this embodiment, the sleeve 1026of the insertion aids 1084 is not heat sealed to the strap 1038, rather,a suture 1042 coupled to the sleeve 1026 is looped through the mesh ofthe strap 1038 at a location 1094 to secure the strap 1038 within thesleeve 1026. After pulling the straps 1038 through a tissue, the sleeve1026 and looped suture 1042 can be cut external to the body at, forexample, a location 1092. The strap 1038 will be released from thesleeve 1026, and the suture 1042 can be pulled out of the mesh of thestraps 1038.

FIGS. 22-27 illustrate example embodiments of implants that areadjustable in length and/or width. Such adjustments to the implant canbe made prior to or during placement of the implant. An adjustment caninclude, for example, cutting the implant, or maneuvering the implantwithin a pelvic region such that the portion of the implant used as asupport portion is adjusted to fit the particularly patient. Theembodiments of an implant described in FIGS. 22-24 can be implanted in apelvic region using any of the various approaches and delivery devicesdescribed herein. Although not necessarily shown for each embodiment,any of the implants can include sleeves and/or dilators and/or insertionaids to protect the implant during insertion. The implants can alsoinclude various connectors for associating the implant to a deliverydevice (e.g., a delivery device 164 or a delivery device 264) andvarious anchoring mechanisms (e.g., tangs, dimples).

As shown in FIG. 22, an implant 1120 includes anterior straps 1134,mid-line straps 1136, posterior straps 1138, an anterior support portion1144 and an extended posterior support portion 1146. FIG. 22 illustratestwo overlaid portions shown with dashed lines indicating examples ofpossible size adjustments to the anterior support portion 1144. Theoutline 1144′ illustrates an example of how the implant 1120 can beadjusted to provide a larger anterior support portion to fit a largepelvic region. For example, to provide a support portion 1144′ that islarger than the support portion 1144, the straps can be placed (e.g.,pulled) through pelvic tissue only up to the location of the dashed lineof 1144′. Such placement of the straps provides a support portion 1144′that includes a portion of the straps and is larger than the supportportion 1144.

The outline 1144″ illustrates an example of how the implant 1120 can beadjusted to accommodate a smaller support portion to fit a small pelvicregion. In this example, the straps can be pulled further into thepelvic tissue up to the location of the dashed-line of 1144″. Suchplacement of the straps provides a support portion 1144″ that is smallerthan the support portion 1144′, because a larger portion of the straps,and in some cases, portions of the support portion 1144 are pulled intothe pelvic tissue.

The area illustrated between the large outline 1144′ and the smalloutline 1144″ illustrates an example of the amount that the implant 1120can be adjusted as the straps (1134, 1136, 1138) of the implant 1120 arepulled into pelvic tissue. In this embodiment, the straps 1136 arelarger in width near the support portion 1144, which can provide moresurface area for anchoring to the surrounding tissue. Thus, in someembodiments, a portion of the straps 1136 shown within the large outline1144′ can act as a support portion for larger patients, for example, bynot being pulled into the tissue. In some embodiments, a portion of thestraps 1136 within the large outline 1144′ can be displaced or pulledinto a tissue or ligament, resulting in a smaller support portion 1144″,to accommodate a smaller sized patient.

The straps 1134, 1136, 1138 of the implant 1120 can have a length suchthat they can extend to the respective tissue securement sites, but arenot long enough to extend further (e.g., within a vagina or through anexterior incision through the skin of the patient). The straps can bedelivered into a pelvic region using a delivery device as describedherein. FIG. 23 illustrates an example of a sleeve assembly 1154 thatcan be disposed over the straps to assist in the delivery process aspreviously described. FIG. 23 shows a sleeve assembly 1154 disposed overa strap 1138 for illustration purposes. The same or different sleeveassembly, dilator or other connector can also be coupled to the otherstraps of implant 1120.

The sleeve assembly 1154 includes a tapered sleeve 1126, a dilator 1128molded to the sleeve 1126 and onto a leader 1130. A trocar needle 1132is coupled to an end of the leader 1130. A suture 1142 is looped withinthe sleeve 1126 and is threaded through the strap 1138 and into theanterior support portion 1144. The suture 1142 secures the sleeve 1126to the strap 1138 and helps prevent elongation of the strap 1138 duringplacement. To form the loop, the suture 1142 is threaded into the end ofthe strap 1138, from a distal end of the strap 1138 toward the anteriorsupport portion 1144. The suture 1142 is looped around 90 degrees withinthe support portion 1144, and threaded back through the strap 1138. Theends of the suture 1142 are then secured to each other with a knot 1170to form a closed loop. The knot 1170, or a portion of the suture 1142near the knot 1170, can be coupled to the sleeve with, for example, aheat seal or an adhesive (not illustrated in FIG. 23). In alternativeembodiments, a suture loop is threaded through only a portion of astrap. In some embodiments, the leader extends through a lumen of thedilator and a loop is formed (e.g., knotted or crimped) at a proximal ortrailing end of the dilator.

The sleeve assembly 1154 can be pulled through a tissue (e.g., ligament,muscle, or soft tissue), for example, into a sacrospinous ligament or anarcus tendineus, using a delivery device, such as the delivery device164 described herein. After pulling the sleeve assembly 1154 through thetissue, the sleeve assembly 1154 can be cut extracorporeal as describedabove for previous embodiments. For example, after pulling the sleeveassembly 1154 through a tissue, the sleeve 1126 and suture 1142 can bepulled through a vaginal incision and cut, for example, at a location Ashown in FIG. 23. The sleeve 1126 can then be pulled off the strap 1138and the suture 1142 can be pulled to unravel or otherwise release thesuture 1142 from the strap 1138 and support portion 1144.

FIG. 24 illustrates another embodiment of a sleeve assembly disposedover a strap 1138 of the implant 1120. In this embodiment, a sleeveassembly 1154′ includes a tapered sleeve 1126′, a dilator 1128′, leader1130′ and trocar 1132′. Only a small portion of the strap 1138 isdisposed within the sleeve 1126′. The strap 1138 is coupled to thesleeve 1126′ with a heat seal 1168. The sleeve 1126′ extends over only aportion of the strap 1138, and therefore, only protects or covers thatportion of the strap 1138 during the delivery procedure. In thissituation, however, only a small portion of the strap 1138 will be incontact with tissue during delivery (due to the short length of thestrap). As with the previous embodiment, the sleeve 1126′ and a portionof the strap 1138 can be cut after inserting the strap 1138 throughtissue. For example, the sleeve 1126′ and strap 1138 can be cut at alocation A as shown in FIG. 24.

FIG. 25 illustrates the implant 1120 with sleeves removed and in anexample orientation within a pelvic region (pelvic region not shown). Asshown in FIG. 25, the posterior support portion 1146 can be tucked intothe posterior fascia within the pelvic region (not shown). In somecases, for example, for a patient having a uterus, it may be desirableto cut the implant along dotted line B. In such a case, the posteriorsupport portion 1146 can be discarded or placed separately around theposterior area of the vagina. The posterior support portion 1146 canoptionally be trimmed to a desired length by cutting the posteriorsupport portion 1146 along, for example, dotted line C.

Each of the straps 1134, 1136, 1138 can be delivered to a pelvic regionthrough an anterior vaginal incision. The mid-line straps 1136 andposterior straps 1138 are angled towards the posterior of the implant1120 so that excess implant material is displaced towards the posteriorend of the implant 1120. The mid-line straps 1136 can be implanted, forexample, into an arcus tendineus and the posterior straps 1138 can beimplanted, for example, into a sacrospinous ligament. The anteriorstraps 1134 can be placed into, for example, an arcus tendineus or anobturator membrane or muscle. The order of delivering the straps canvary as described above. A posterior vaginal incision can be made toprovide access to the posterior support portion 1146 for wrapping theposterior support portion 1146 around a vaginal cuff and tucking it intoa desired position. The straps 1134, 1136, 1138 can be tensioned in anyorder. The anterior straps 1134 can help position the anterior supportportion 1144 anteriorly and laterally. The mid-line straps 1136 (e.g.,secured to the arcus tendineus) can provide lateral support to theanterior support portion 1144. The posterior straps 1138 (e.g., securedto the sacrospinous ligament) can provide a deeper anchor point and adesired angle for vaginal support.

FIG. 26 illustrates an implant similar to the implant 1120 but haslonger straps than the implant 1120. An implant 1220 includes anteriorstraps 1234, mid-line straps 1236, posterior straps 1238, an anteriorsupport portion 1244 and an extended posterior support portion 1246.FIG. 26 illustrates an overlaid portion 1244′ that indicates an exampleof a possible size adjustment to the anterior support portion 1244. Theoutline 1244′ illustrates a larger anterior support portion to fit alarge pelvic region described in more detail below. The implant 1220 canbe delivered using any of the methods and devices described herein. Thestraps of the implant 1220 allow the implant 1220 to also be deliveredusing various other delivery devices not specifically described herein.

The area illustrated between the large outline 1244′ and the smalleroutline of the support portion 1244 illustrates the amount the implant1220 can be adjusted in both length and width. As described previouslyfor implant 1120, the straps (1234, 1236, 1238) of the implant 1220 canbe pulled into pelvic tissue varying amounts to adjust the effectivesize of the anterior support portion 1144. For example, the straps canbe pulled into pelvic tissue until a desired amount of the supportportion 1244 is positioned within an anterior region of the pelvis. Insome embodiments, a portion of the anterior support portion 1244 ispulled into the pelvic tissue such that a smaller portion of the supportportion 1144 is disposed within the anterior region of the pelvis. Insome embodiments, the straps are only pulled partially into the tissue,for example, up to the border of the outline 1244′, such that a portionof the straps is disposed within the anterior region of the pelvis. Insuch a case, the portion of the straps remaining in the anterior regionof the pelvis increasing the effective size of the support portion 1244.Thus, a portion of the straps within the large outline 1244′ can act asa support portion for larger patients, or can be displaced or pulledinto tissue to accommodate a smaller patient.

FIG. 27 illustrates another embodiment of an implant that is similar tothe implant 1120. An implant 1320 includes anterior straps 1334,mid-line straps 1336, posterior straps 1338, an anterior support portion1344 and a posterior support portion 1346. The implant 1320 can becustom-fit for an individual patient by cutting a selected portion ofthe implant 1320. For example, a portion or the entire length of dottedlines A, B, C and/or D can be cut to provide a custom fit for a smallerpatient. In one example, cutting the dotted lines A and B lengthens themid-line straps 1336 and enables the mid-straps 1336 to be pulledfurther into pelvic tissue, or to reach securement sites within thepelvis that they would otherwise not be able to extend to. For example,lengthening the mid-line straps 1336 allows the mid-line straps 1336 tobe passed through a mid-arcus (of an arcus tendineus). In anotherexample, dotted lines C and D can be cut to allow the posterior straps1338 to be pulled further into tissue. By pulling the straps 1338further into tissue, the anterior support portion 1344 of the implant1320 within the anterior region of the pelvis will be smaller. In someembodiments, it may be desirable to cut along lines A, B, C and D tolengthen the straps 1336 and 1338.

FIG. 28 illustrates an embodiment of an implant that includes attachablesleeve and strap assemblies that can be coupled to a support portion ofa pelvic implant prior to, or after implantation into a pelvic region.An implant 1420 includes an anterior support portion 1444, sleeve andstrap assemblies 1496 and 1496′ attached to the anterior support portion1444 at corners J and H, respectively, and sleeve and strap assemblies1498 and 1498′ attached to the anterior portion 1444 at corners F and G,respectively. A separate suture and needle (not shown) can be used tosecure the strap of the sleeve and strap assemblies 1496, 1496′, 1498,1498′ to the support portion 1444. In other embodiments, otherattachment methods can be used to secure the straps to the supportportion, such as, for example, heat bonding, gluing, or using fasteners.The sleeve and strap assemblies 1496, 1496′, 1498, 1498′ can each beattached to the support portion 1444 by a user (e.g., a physician ormedical technician) prior to implantation or after the sleeve and strapassemblies have been passed through a pelvic tissue. The sleeve andstrap assembly 1498 is constructed the same as the sleeve and strapassembly 1498′ and will be collectively described below. Similarly, thesleeve and strap assembly 1496 is constructed the same as the sleeve andstrap assembly 1496′ and will be collectively described below.

The sleeve and strap assemblies 1498, 1498′ include a sleeve 1493,1493′, a strap 1438, 1438′ and a low profile connector 1499, 1499′. Thesleeve and strap assemblies 1496, 1496′ include a sleeve 1495, 1495′ anda loop connector 1497, 1497′. A suture 1442 is used to secure each ofthe straps (1434, 1434′, 1438, 1438′) to its respective sleeve (e.g.,1493, 1493′, 1495, 1495′). For example, as shown for the sleeve andstrap assembly 1498′, a suture 1442 is secured to the strap 1434′ atpoint A, threaded through the inside of the sleeve 1493′ and secured tothe low profile connector 1499′ at or about point B. A similar suture1442 is secured to each of the other strap assemblies in a similarmanner. A single strand of suture 1442 is depicted, but it should beunderstood that multiple strands can be used in other embodiments.

The connectors 1499, 1499′ and connectors 1497, 1497′ can each be usedto associate to a delivery device, such as the delivery device 264described above to deliver each of the straps of the implant 1420 to aselected tissue site. The sleeve and strap assemblies 1498, 1498′ can beused to secure the straps 1438 to, for example, a sacrospinous ligamentor tendineus arch of the levator ani muscle. The sleeve and strapassemblies 1496, 1496′ can be used to secure the straps 1434, 1434′ to,for example, an arcus tendineus or an obturator muscle or membrane.

Each of the sleeve and strap assemblies 1496, 1496′, 1498, 1498′ can bepulled through a desired tissue site, and retrieved external to thepatient's body, through for example, a vaginal incision or an exteriorincision. Once all of the sleeve and strap assemblies 1496, 1496′, 1498,1498′ are positioned, the sutures 1424 or both the sutures 1424 and therespective sleeve 1493, 1493′, 1495, 1495′ can be cut to release themfrom their respective strap in a similar manner as described above forother embodiments. The sleeves 1493, 1493′, 1495, 1495′ are then pulledoutward away from the body of the patient to leave the straps 1434,1434′, 1438, 1438′ to engage the surrounding tissue. The sutures 1424remain attached to the straps, for example, at point A, allowing thesutures 1424 to be used to retrieve a cut strap portion after trimmingthe strap, if needed.

FIG. 29 illustrates another embodiment of an implant similar to theprevious embodiment. An implant 1520 includes a sleeve and strapassembly 1598 and a sleeve and strap assembly 1596. The sleeve and strapassemblies 1598 and 1596 are each coupled to a support portion 1544 ofthe implant 1520. The sleeve and strap assembly 1598 includes a singlestrap 1591, and a pair of sleeves 1593 and 1593′ disposed over oppositeends of the strap 1591. Similarly, the sleeve and strap assembly 1596includes a single strap 1589, and a pair of sleeves 1595 and 1595′disposed over opposite ends of the strap 1589. Other components of thesleeve and strap assemblies 1598 and 1596 are substantially the same asthe sleeve and strap assemblies 1498 and 1596, respectively. Forexample, a suture 1542 can be used to secure the straps of the implant1520 to the sleeves.

In this embodiment, the sleeve and strap assembly 1598 is coupled alongan edge 1587 of the support portion 1544 as indicated at R. The sleeveand strap assembly 1496 is coupled to the support portion 1544 along anedge 1585 as indicated at S. Each of the ends of the strap 1591 can besecured to a tissue site in a similar manner as described above forstraps 1438 and 1438′. Likewise, the ends of strap 1589 can be securedto a tissue site in a similar manner as described above for straps 1434and 1434′.

Another similar embodiment of an implant is illustrated in FIG. 30. Animplant 1620 includes a support portion 1644, two proximal anteriorstraps 1634, 1634′, and two distal anterior straps (or posterior straps)1638, 1638′. The straps can be formed as a single component with thesupport portion 1644 or can be attachable as in the previous twoembodiments.

A proximal end portion 1681 of the support portion 1644 is disposedwithin a sleeve assembly 1679 having a center tab 1677 joining twohalves 1695, 1695′ of the sleeve assembly 1679. The straps 1634, 1634′are disposed free-floating within the sleeve halves 1695, 1695′. Aportion of the support portion 1644 is not disposed within an interiorregion defined by the sleeve assembly 1679, but in some embodiments thesleeve assembly can include flaps (not shown) that can extend to cover alarger portion of the support portion 1644.

FIG. 31 illustrates a portion of the implant 1620 including a sleeveassembly 1698′ having a sleeve 1693′ and a low profile connector 1699′,disposed over the strap 1638′. A similar sleeve assembly 1698 isdisposed over the strap 1638 (shown in FIG. 30) and includes a sleeve1693 and a low profile connector 1699. As illustrated in FIG. 31, asuture 1642 is knotted at a first end 1675 and a second end of thesuture 1642 is threaded through a first wall or top portion of sleeve1693′ at location A (with the knot preventing the suture 1642 from beingpulled through the top portion of the sleeve 1693′), through the strap1638′, and through a second wall or bottom portion of the sleeve 1693′(on a bottom side and not shown in FIG. 31). The second end of thesuture 1642 is then run external to the second wall along a length ofthe sleeve 1693′ to a location B where it is threaded back through thesecond wall of the sleeve 1693′, through the strap 1638′ and through thefirst wall of the sleeve 1693′. In some embodiments, the suture 1642 istensioned or adjusted in length such that the strap 1638′ and suture1642 are substantially equal in length. A knot 1670 is formed at thesecond end of the suture 1642 at location B to secure the suture 1642 tothe sleeve 1693′. In other embodiments, the second end of the suture canbe coupled to the sleeve by other means, and/or coupled to the lowprofile connector 1699′. For example, the second end of the suture canbe secured to the sleeve 1693′ and/or connector 1699′ by a heat seal,gluing, molding, or tying. In some embodiments, the suture can extendfrom A to B along an inside of the sleeve.

The implant 1620 can be implanted into a pelvic region in the samemanner as described for other embodiments. For example, an implant 1620can be delivered into a pelvic region using an inside-out approach, anoutside-in approach, supra-pubic approach, or transvaginal approach.After each of the straps 1638 and 1638′ with their respective sleeveassembly 1698, 1698′ is pulled through a selected tissue site, and anynecessary adjustments and/or tensioning is complete, the sleeveassemblies and sutures can be removed from the strap in a similar manneras described for previous embodiments. For example, the sleeve andsuture can be cut at location C (See FIG. 31), to allow the sleeve (withattached suture) to be pulled off the strap. In some embodiments, onlythe sleeve is cut, as the suture is coupled to the sleeve. In someembodiments, only a suture end is cut (e.g., the knot 1670 is cut off)to release the sleeve from the strap.

The sleeve assembly 1679 disposed over the straps 1634 and 1634′ (seeFIG. 30) can also be removed after passing the strap through a pelvictissue. After the straps 1634 and 1634′ are pulled through a selectedtissue site, the sleeve assembly 1679 can be removed by making a cutthrough an opening 1673 on the center tab 1677, which releases the twosleeve halves 1695 and 1695′. The two cut portions of the center tab1677 can be removed and discarded. The sleeves 1695 and 1695′ can bepulled to remove them from the straps 1634 and 1634′, leaving the straps1634 and 1634′ to engage the surrounding tissue.

FIG. 32 illustrates a portion of an embodiment of an implant similar tothe implant 1620 described above. An implant 1720 includes proximalanterior straps 1734 and distal anterior straps (or posterior straps)1738 and a support portion 1744. In this embodiment, sleeve assemblies1796, include a sleeve 1795 and a connector 1797, and are disposed overeach of the straps 1734. The sleeve assembly 1796 is coupled to a strap1734 with a suture 1742. The suture 1742 is secured to the strap 1734 byknotting or tying the suture 1742 to the strap 1734 at location A. Thesuture 1742 is then extended through an inside of the sleeve 1795 to alocation B where it is secured to the sleeve 1795 and/or connector 1797by knotting, using a heat seal or adhesives or other coupling methods.

Similarly, sleeve assemblies 1798, include a sleeve 1793 and connector1799, and are disposed over each of the straps 1738. A suture 1742 issecured to a strap 1738 by tying or knotting the suture 1742 to thestrap 1738 at location C. Although not shown in FIG. 32, the suture 1742can be extended through an inside of the sleeve 1793 to a location Dwhere it can be secured to the sleeve 1793 and/or connector 1799 asdescribed for sleeve assemblies 1796. FIG. 32 illustrates the sleeve1793 removed from the strap 1738 for illustration purposes. In thisembodiment, each of the sutures 1742 remain coupled to the straps 1738and the straps 1734 after removing the sleeve assemblies 1798 and 1796.For example, as shown in FIG. 32, to remove the sleeve assembly 1798from the strap 1738, the suture end at location D can be cut allowingthe sleeve 1793 to be pulled off the strap 1738. The suture end atlocation C will remain secured to the strap 1738. When the strap 1738 istrimmed (if needed), the suture 1742 (still secured to the cut portionof the strap), can then be used to retrieve the cut portion of thestrap. The sleeve assembly 1796 can be removed from the strap 1734 in asimilar manner.

FIGS. 33-36 each illustrate an embodiment of a sleeve assembly that canbe used to assist in the implantation of a strap of an implant. Each ofthe embodiments of FIGS. 33-36 can be coupled to a delivery device, suchas delivery device 164, and can be inserted into a pelvic region usingany of the approaches described herein. FIG. 33 illustrates anembodiment of a sleeve assembly 1854 associated to a strap 1838 of animplant 1820 for illustration purposes. Thus, the sleeve assembly 1854can be coupled to a variety of different types of straps of a variety ofdifferent types or configurations of an implant.

The sleeve assembly 1854 includes a sleeve 1826 and a dilator 1828coupled to the sleeve 1826. A suture 1842 forms a loop inside of thesleeve 1826 and is threaded through the strap 1838. The suture 1842extends through the dilator 1828 and exits a distal end portion 1871 ofthe dilator 1828. A heat seal 1868 can be used to secure the suture 1842to the sleeve 1826. The portion of the suture 1842 extending outside thedilator 1828 is the leader 1830. A trocar needle 1832 is coupled to anend of the leader 1830 and can be used to associate to a delivery deviceas described above. An opposite end of the suture 1842 can be knottedwithin the dilator 1828 (not shown in FIG. 33) to secure it thereto andform the loop within the sleeve 1826.

The dilator 1828 is relatively long and smooth and tapers to the endportion 1871. As described previously for other embodiments, the dilator1828 can expand a passage formed by the trocar needle 1832 duringinsertion through a tissue, to ease the transition to a cross-section ofthe sleeve 1826. The sleeve 1826 is also tapered, which helps provide alead-in through the passage formed by the dilator 1828 through thetissue. As shown in FIG. 33 a length of the sleeve 1826 is greater thana length of the strap 1838. In some embodiments, the tapered sleeve 1826can be long enough to extend out of the vagina during delivery so thatthe suture 1842 can be cut external to the body.

In one example, the sleeve assembly 1854 can be coupled to a strap(e.g., strap 1838), using the suture 1842. The suture 1842 is threadedthrough the sleeve 1826 and attached to a trailing end of the dilator1828. A trailing end 1869 of the sleeve 1826 is positioned over thestrap 1838. The tapered dilator tip 1871 is associated over a knot (notshown) formed with the suture 1842, to secure the dilator 1828 to thesuture 1842. For example, the dilator 1828 can be molded or formed overthe knot. FIG. 34 illustrates a portion of an alternative embodiment ofa sleeve assembly, where a suture 1842′ is threaded through a portion ofthe strap 1838 and a knot 1870 is tied to form a suture loop. A separateleader suture (not shown) can then be coupled to a leading end of thedilator.

FIG. 35 illustrates a sleeve assembly that does not include a dilator. Asleeve assembly 1954 includes a sleeve 1926, a suture 1942, and a trocarneedle 1932 coupled to an end of a leader 1930. The sleeve 1926 istapered such that it can provide a lead-in through pelvic tissue and isalso configured to dilate the tissue as it is being drawn through thetissue. The suture 1942 can be used to secure a strap, such as strap1938 shown in FIG. 35, to a support portion of an implant 1920. In thisembodiment, the sleeve 1926 only covers a portion of the strap 1938.

To secure the suture 1942 to the strap 1938, two ends of the suture 1942are threaded into and near a corner of the implant 1920 at location D.The two ends are passed back through a loop formed in the suture 1942 tosecure the suture 1942 to the implant 1920. The two suture ends are thenthreaded through the strap 1938 and tied (e.g., knotted) to the strap1938 at intervals up to, for example, a location A. At this point, thesuture 1942 is not secured to the sleeve 1926. The suture ends are thenthreaded through the inside of the sleeve 1926 to a location B where thesuture 1942 is secured to the sleeve 1926. For example, a heat seal canbe used to secure one end of the suture 1942 to the sleeve 1926. Theother end of the suture 1942 exits the end of the sleeve 1926 and formsthe leader 1930.

As with previous embodiments, the trocar needle 1932 that is coupled tothe leader 1930 can be associated to a delivery device, such as, forexample, delivery device 164, and used to deliver the implant strap to atissue site. In the area of location C, the suture 1942 and sleeve 1926can be cut to release the sleeve 1926 from the strap 1938. After beingcut, a portion of the suture 1942 that is attached to the sleeve 1926(at location B) is discarded. The portion of the suture 1942 that isattached to the strap 1938 at location A remains attached to the strap1938, as the sleeve 1926 is removed. The suture portion attached to thestrap 1938 at A can subsequently be used to remove a trimmed portion ofthe strap 1938. The suture portion attached to the implant 1920 atlocation D and along the strap 1938 can remain attached to the strap1938.

In other embodiments, the suture can be coupled to the sleeve by othermeans. For example, the suture can be molded to a connector at locationB, tied to a connector, tied to one wall of the sleeve, tied to bothwalls of the sleeve, or otherwise secured. In some embodiments, morethan one suture can be used. The suture can optionally be disposedexternal to the sleeve to facilitate cutting of the suture only, and notthe sleeve. For example, the sleeve can include a window or openingexposing a portion of the suture.

FIG. 36 illustrates a sleeve assembly that is similar to the sleeveassemblies 1854 and 1954. In this embodiment, a sleeve assembly includesa dilator to aid in dilating an insertion tract. A sleeve assembly 2054includes a sleeve 2026, a tapered dilator 2028, a suture 2042, and atrocar needle 2032 coupled to an end of a leader 2030. The sleeveassembly 2054 is constructed the same as the sleeve assembly 1954 exceptfor the addition of the dilator 2028. The suture 2042 can be secured tothe sleeve 2026 and/or dilator 2028.

FIGS. 37-48 illustrate various embodiments of implants that can be used,for example, to repair a cystocele and a rectocele. Such implantsinclude straps to secure an anterior support portion of an implant to ananterior region of a pelvis (e.g., to an arcus tendineus or obturator),and straps to secure a posterior support portion of the implant to aposterior region of the pelvis (e.g., a sacrospinous ligament). In somecases, an implant can be cut into two pieces to use as two separateimplants, for example, an implant to be placed in an anterior region ofa pelvis and an implant to be placed in a posterior region of a pelvis.Although not necessarily shown, each of the implants can be formed inpart or wholly with a mesh material. The implants can include a sleeveassembly or dilator assembly disposed over one or more of the straps ofthe implant, as described herein, to use during the placement of theimplant. The implants can alternatively include a coupling feature(e.g., on a strap) to associate a strap of the implant to a deliverydevice. The implants can also be secured to a pelvic tissue usingsutures.

An implant 2120 includes two anterior straps 2134 and two mid-linestraps 2136 extending from an anterior support portion 2144, and twoposterior straps 2138 extending from a posterior support portion 2146.The implant 2120 also includes posterior reinforcement straps 2167 andanterior reinforcement straps 2165, which are configured to help locateand support the posterior straps 2138. In this embodiment, the posteriorstraps 2138 are substantially perpendicular to a centerline CL of theimplant 2120, and the reinforcement straps 2167 are angled and extendtoward the posterior at, for example, an angle α (relative to thecenterline CL) of approximately 48 degrees. In other embodiments,reinforcement straps 2167 can be angled, for example, between about 15and 80 degrees. Each of the different straps can be placed within apelvic region using the methods and devices described herein. Forexample, the anterior straps 2134 can be secured to an arcus tendineusor an obturator (muscle or membrane), the mid-line straps 2136 can besecured to an arcus tendineus, and the posterior straps 2138 can besecured to a sacrospinous ligament. The posterior support portion 2146can be wrapped around a vaginal cuff as described above for otherembodiments. For example, the implant 2120 can be folded or curved overat a vaginal wrap portion 2141, as shown in FIG. 37.

FIG. 38 illustrates another implant similar to the implant 2120 but theposterior straps are angled rather than being perpendicular with respectto a centerline of the implant. An implant 2220 includes two anteriorstraps 2234 and two mid-line straps 2236 extending from an anteriorsupport portion 2244, and two posterior straps 2238 extending from aposterior support portion 2246. The implant 2220 also includes posteriorreinforcement straps 2267, and anterior reinforcement straps 2265. Inthis embodiment, the posterior straps 2238 are angled with respect to acenterline CL of the implant 2220.

A dashed fold line 2263 is included near an end of each strap. The foldlines 2263 can be used to indicate where the straps can be associated toa dilator or sleeve device. The straps can also be folded at the foldlines 2263 to make the association to, for example, a loop connector ofa dilator or sleeve device easier. The posterior reinforcement straps2267 can provide, for example, posterior apical support. The anteriorsupport portion 2244 can support the anterior portion of the vagina, forexample, for cystocele repair. The implant 2220 can be wrapped around avagina at location 2241 to support the vaginal cuff for example, for anenterocele repair. The posterior support portion 2246 can providesupport to the posterior side of the vagina, for example, for rectocelerepair. The implant 2220 can be placed and secured to pelvic tissueaccording to the methods described herein. For example, the anteriorstraps 2234 can be placed through an obturator, retro-pubically,supra-pubically or pre-pubically. The mid-straps 2236 can be placed, forexample, through an arcus tendineus or distal to the ischial spine. Theposterior straps 2238 can be placed, for example, through a sacrospinousligament.

FIG. 39 is a schematic side-view of the implant 2220 oriented in anexample position within a pelvic region. As shown, the implant 2220 canbe placed in an anatomically-correct vaginal angle of support θ when theimplant 2220 is secured, for example, to the arcus tendineus AT and thesacrospinous ligament SSL. FIG. 39 illustrates the attachment of straps2234, 2236, and 2238 and the position and orientation of the posteriorreinforcement straps 2267, the anterior support portion 2244, thevaginal wrap 2241 and the posterior support portion 2246.

FIG. 40 illustrates another embodiment of an implant. An implant 2320includes anterior straps 2334, midline straps 2336 and posterior straps2338. The posterior straps 2338 extend from an anterior support portion2344 and are connected to posterior reinforcement straps 2367. Theposterior reinforcement straps 2367 extend from a posterior supportportion 2346. Each of the straps include grooves or recessed portions2361 to indicate where to attach to a dilator or sleeve assembly (notshown). The implant 2320 can be placed according to the methodsdescribed herein.

For example, a dilator (not shown) can be associated to a posteriorstrap 2338 and used to draw both the posterior strap 2338 and itsassociated posterior reinforcement strap 2367 through, for example, asacrospinous ligament at the same time. The posterior straps 2338 andthe posterior reinforcement straps 2367 can be used, for example, tosupport both the anterior support portion 2344 and the posterior supportportion 2346 of the implant 2320 within the pelvic region. The posteriorsupport portion 2346 can be tucked around the vaginal cuff and/orsecured, for example, with sutures, to a posterior vaginal compartment,to provide posterior support. For example, the posterior portion 2346can be wrapped at 2341 and tucked in a direction of arrow M shown inFIG. 40.

The anterior straps 2334 and midline straps 2336 can be secured forexample, to an arcus tendineus to support the anterior support portion2344 within the pelvic region. The anterior support portion 2344 canalso optionally be further secured with sutures, to, for example, pelvicfascia or the vaginal cuff to complete an apical support.

FIGS. 41-43 illustrate an implant that is similar to the implant 120illustrated in FIG. 3. An implant 2420 includes anterior straps 2434 andmiddle straps 2436 that extend from an anterior support portion 2444,and posterior straps 2438 that extend from a posterior support portion2446. A vaginal wrap portion 2441 is disposed between the anteriorsupport portion 2444 and posterior support portion 2446. The implant2420 can be placed in a pelvic region using methods and devicesdisclosed herein. The straps 2434, 2436, 2438 can include tangs asdescribed above and/or can include barbs or other protrusions configuredto engage tissue. The anterior straps 243 also include dimples 2440configured to increase the holding strength of the anterior straps 2434.

FIG. 42 is an enlarged view of an anterior strap 2440, and FIG. 43 is anenlarged side view of a portion of a strap 2434 illustrating a profileof the dimples 2440. As shown in FIG. 43, the dimples 2440 are disposedin alternating, opposed directions on the top and bottom surfaces of thestrap 2434. The number of dimples 2440 can vary and can also be includedon other straps of the implant and/or some or all of the supportportions 2444 and 2446. The dimples 2440 can be sized and shaped asdescribed above for implant 120.

FIG. 44 illustrates an embodiment of an implant having eight straps. Animplant 2520 includes six straps extending from an anterior supportportion 2544 and two posterior straps 2538 extending from a posteriorsupport portion 2546. The straps extending from the anterior supportportion 2544 include anterior straps 2534, first or anterior midlinestraps 2536 and second or posterior midline straps 2537. The implant2520 also includes a vaginal wrap portion 2541 disposed between theposterior support portion 2546 and the anterior support portion 2544.

The various straps of the implant can be placed within a tissue siteindividually as described in previous embodiments, or alternatively theposterior straps 2538 can be combined with second midline straps 2537(on one side of the implant) and placed together at a tissue site withina pelvic region. The posterior straps 2538 and second midline straps2537 on the contra-lateral side can likewise be combined for placement.For example, the posterior straps 2538 and second midline straps 2537can be combined and passed through a sacrospinous ligament. The anteriorstraps 2534 and first midline straps 2536 can be placed according tomethods disclosed herein.

FIG. 45 illustrates an implant 2620 that can be placed within a pelvicregion in its entirety, or can be cut, for example, along a dashed lineC to form a posterior repair implant 2646 and an anterior repair implant2644. When implant 2620 is cut, both anterior repair implant 2644 andposterior repair implant 2646 can be individually placed into a pelvicregion of a patient as needed for the particular condition.Alternatively, a portion of the implant not used can be discarded orsaved for a later use. The versatility of implant 2620 allows aphysician flexibility in fashioning the most appropriate procedure forthe patient. The various straps of the implant 2620 can be placedaccording to the methods and devices described herein.

FIG. 46 illustrates another embodiment of an implant having six straps.An implant 2720 includes a pair of anterior straps 2734 and fourposterior straps 2738, 2738′. Similar to the implant 1320 (FIG. 27) theimplant 2720 can be adjusted to fit a particular patient. The implant2720 includes dashed cut lines C1, C2, C3, C4 that indicate examplelocations where the implant 2720 can be cut, either entirely orpartially, to fit the patient. For example, as described above forimplant 1320, cutting the implant along lines C1 and C2 allows theposterior straps 2738 to be pulled further into a tissue. Cutting alonglines C3 and C4 allows the posterior straps 2738′ to be pulled furtherinto tissue. The posterior straps 2738′ can be anchored, for example, toa sacrospinous ligament (SSL) or an arcus tendineus, or can be removed(cut-off) from the implant 2720. Similarly, posterior straps 2738 can beanchored to the arcus tendineus or the SSL, or can be removed from theimplant 2720. In one example modification of the implant 2720, if theposterior straps 2738′ are removed (e.g., cut off), implant 2720 canoptionally be anchored to the arcus tendineus using straps 2738, ratherthan securing the straps 2738 to the SSL. In another example, if theposterior straps 2738 are removed, the implant 2720 can be anchored, forexample, to the SSL, using the straps 2738′. Implant 2720 can be placedwithin a pelvic region using the methods and devices described herein.

FIG. 47 illustrates an implant having sleeve assemblies attached to itssix straps. An implant 2820 includes anterior straps 2834 a, 2834 b andmidline straps 2836 a, 2836 b extending from an anterior support portion2844, and posterior straps 2838 a, 2838 b extending from a posteriorsupport portion 2846. Various embodiments of a sleeve assembly aredisposed over the straps. The sleeve assemblies are similar to thosedescribed herein. For example, the sleeve assembly 2854 disposed overstrap 2834 a (and 2834 b) is similar to the sleeve assembly describedwith reference to FIG. 9. The sleeve assembly 2854 includes a loopconnector 2866 to associate to a delivery device having an engagementnotch, such as delivery device 264. The sleeve assembly 2854′ disposedover strap 2836 a (and 2836 b) and the sleeve assembly 2854″ disposedover strap 2838 a (and 2838 b) are each similar to the sleeve assembliesdescribed with reference to FIG. 23 and FIG. 33. The sleeve assemblies2854′ and 2854″ each include a dilator 2828′, 2828″ and a trocar needle2832′, 2832″ to associate to a delivery device such as delivery device164. As described above for previous embodiments, each of the straps ofthe implant 2820 are shorter in length than its surrounding sleeve,reducing the need to trim the length of the strap after placement.

Implant 2820 can also be cut into an anterior repair implant and aposterior repair implant as described above with reference to FIG. 45.In this embodiment, protrusions 2859 are provided on lateral sides of avaginal wrap portion 2841 of the implant 2820 to indicate a cut locationfor separating the anterior support portion 2844 from the posteriorsupport portion 2846. For example, when a patient has a uterus, thetotal repair implant 2820 can be separated (cut into two parts) and theanterior support portion 2844 and posterior support portion 2846 caneach be positioned separately, rather than wrapping the posteriorsupport portion 2846 around the vaginal cuff of a hysterectomy patient.

FIG. 48 illustrates a three-dimensional view of the implant 2820simulating a deployed configuration within a patient. The position ofimplant 2820 illustrated in FIG. 48 can be obtained, for example, bysecuring the mid-straps 2836 a, 2836 b to an arcus tendineus (onopposite sides of a pelvis, the anterior straps 2834 a, 2834 b to anobturator muscle or membrane (on opposite sides of the pelvis) and theposterior straps 2838 a, 2838 b to a sacrospinous ligament (on oppositesides of the pelvis). The posterior support portion 2846 is shown afterbeing wrapped around a vaginal cuff and positioned to provide support tothe posterior side of the vagina.

As shown in FIG. 47, prior to placing the implant 2820 within a pelvicregion, the posterior straps 2838 a and 2838 b are angled toward theanterior straps 2834 a, 2834 b and the mid straps 2836 a, 2836 b. When,however, the implant 2820 is deployed within a pelvic region and theposterior support portion 2846 is wrapped around a vaginal cuff (e.g.,of a hysterectomy patient), the posterior straps 2838 a, 2838 b areangled in a direction of the sacrospinous ligaments (SSL) as shown inFIGS. 48 and 49.

FIG. 49 illustrates the deployment of the implant 2820 within aschematic illustration of a pelvic region. The procedure describedapplies to securement of straps of the implant 2820 on both sides of thepelvic region. FIG. 49 illustrates the implant 2820 without the sleeveassemblies attached to the straps. Implant 2820 is configured to bedelivered in a collapsed configuration through an anterior and/orposterior vaginal incision. For example, an anterior incision 2857 ismade in a vagina and the implant 2820 is placed though the incision2857. The anterior straps 2834 a, 2834 b are pulled through theobturator foramen O and the sleeve assemblies (not shown) coupled to thestraps 2834 a, 2834 b can be pulled out through the anterior incision2857, as shown by the directional arrows A in FIG. 49. An insertion toolsuch as delivery device 264 can be used for the placement of theanterior straps 2834 a, 2834 b. An apical stitch can also optionally bemade from a midline of implant 2820 to the vaginal apex VA.

The midline straps 2836 a, 2836 b can be pulled through an arcustendineus AT using a suturing device, such as delivery device 164, andthe respective sleeve assemblies (not shown) can be pulled out throughthe anterior incision 2857, as indicated by the directional arrows B.

A posterior vagina incision 2855 can then be made for access to securethe posterior straps 2838 a, 2838 b and position the posterior supportportion 2946. Alternatively, the posterior straps 2838 a, 2838 b andposterior support portion 2946 can be secured via access through theanterior incision. The posterior support portion 2846 can be wrappedaround the posterior side of the vagina. The posterior straps 2838 a,2838 b can be pulled through a sacrospinous ligament SSL using asuturing device, such as delivery device 164, and the respective sleeveassemblies (not shown) can be pulled out through the posterior incision2855, as indicated by the directional arrows C.

When all of the sleeve assemblies have been pulled out through eitherthe anterior incision 2857 or posterior incision 2855, the implant 2820can be adjusted and centered by pulling the sleeve assemblies until adesired implant position is achieved. When the implant 2820 ispositioned correctly, the straps of the implant are released from thesleeve assemblies in a manner as previously described (e.g., by cuttingthe sleeve and/or suture and pulling the sleeve assembly off the strap).Anterior straps 2834 a, 2834 b can be trimmed externally to the body, asnecessary.

Other embodiments of sleeves and/or dilator assemblies can alternativelybe used. In some embodiments, the dilators and sutures withbullet/trocar needles can be replaced with a delivery tube configuredfor use with, for example, the BSC Advantage® or the Prefyx™ deliverydevices and their respective delivery approaches. In some embodiments,the midline straps 2836 a, 2836 b are removed. In such an embodiment,the implant 2820 can be secured, for example, to the arcus tendineuswith the anterior straps 2834 a, 2834 b and/or the anterior supportportion 2844 can be attached to the arcus tendineus using separatesutures.

FIGS. 50-55 each illustrate a different embodiment of an implant. thatcan be used, for example, to treat a rectocele, or provide support to aposterior side of a vagina. These are merely examples of the possibleuses of the implants of FIGS. 50-55, as other uses of the implants arealso possible. An implant can include straps to secure a posteriorsupport portion of the implant to, for example, sacrospinous ligaments.An implant can include a vaginal wrap portion as described above for thetotal repair implants that can be wrapped around a vaginal cuff or anapical portion of a vagina. Although not necessarily shown in FIGS.50-55, each of the implants can be formed in part or wholly with a meshmaterial. The implants can include a sleeve assembly or dilator assemblydisposed over one or more of the straps, as described herein, for useduring the placement of the implant. The implants can alternativelyinclude a coupling feature to associate a strap of an implant to adelivery device. The implants can also or alternatively be secured to atissue using sutures.

As shown in FIG. 50, an implant 2920 includes a posterior supportportion 2946 and two posterior straps 2938 that can each be secured, forexample, to a sacrospinous ligament. The implant 2920 also includes avaginal wrap portion 2941 that can be wrapped around a vaginal cuff orapical area of a vagina as described above for previous embodiments.

FIG. 51 illustrates an implant 3020 that is similar to the implant 2920.In this embodiment, the implant 3020 includes a posterior supportportion 3046 and two posterior straps 3038 that include grooves 3080that can be used to facilitate association of the respective strap to,for example, a dilator device. As with the previous embodiment,posterior straps 3038 can be placed into a sacrospinous ligament foranchoring. The implant 3020 can also be wrapped around a vagina asdescribed above.

FIG. 52 illustrates an implant 3120 that is similar to the implant 3020.The implant 3120 includes a posterior support 3146 and two posteriorstraps 3138, 3138′ that include grooves 3180, 3180′ to facilitateassociation of the respective strap to, for example, a dilator device.Posterior straps 3138, 3138′ can each be anchored, for example, to asacrospinous ligament (SSL). FIG. 53 illustrates a dilator device 3153that can be used to pull the straps 3138, 3138′ through a tissue. Thedilator device 3153 includes a tapered dilator 3128 and a loop connector3151. A strap of an implant 3120′ is shown placed through the loopconnector 3151 to secure it to the dilator device 3153. The dilatordevice 3153 can be associated to a delivery device, such as deliverydevice 164, with a trocar needle 3132. The dilator device 3153 can beused to pull a strap of an implant through a pelvic tissue in the samemanner as described above for the sleeve assemblies.

FIG. 54 illustrates a pair of dilator devices 3153, 3153′ after beingpassed through a schematic representation of sacrospinous ligaments SSLusing for example, a delivery device 164. For example, the dilatordevices 3153 and 3153′ can be passed through an anterior or a posteriorvaginal incision and pulled through an SSL on contra-lateral sides of apelvic region. The straps 3138, 3138′ can each be placed through theloop connectors 3151, 3151′ of the respective dilator devices 3153,3153′ as indicated by the directional arrows E and F, respectively. Thedilator devices 3153, 3153′ can then be used to pull the straps 3138,3138′ through the sacrospinous ligaments. Alternatively, the straps canbe coupled to the dilator devices prior to inserting the dilator devicesinto a pelvic region.

FIG. 55 illustrates the use of dilator devices to deliver both theimplant 320 shown in FIG. 12, and the posterior implant 3120 at the sametime. A schematic representation of the sacrospinous ligaments SSL andthe arcus tendineus AT are also illustrated in FIG. 55. The straps 338,338′ on implant 320 and the straps 3138, 3138′ on implant 3120 arecombined and placed through the loops 3151′ and 3151″ on the dilatordevices 3153′ and 3153″, respectively, as indicated by the paths ofdirectional arrows 1 and H, respectively. A slidable tube member 3131′,3131″ can then be slid over the loops 3151′ and 3151″ in the same manneras described above with reference to FIG. 13. The dilator devices 3153′and 3153″ can then be used to pull the straps 338, 3138 and the straps338′, 3138′ through the sacrospinous ligaments SSL on each side of apelvic region. Placing two straps (e.g. 338, 3138) through a tissue(e.g., the SSL) with one dilator at the same time reduces the proceduretime as well as reduces damage to the SSL during the delivery process.The dilator devices can be placed in the SSL by either an anterior orposterior vaginal incision.

The straps 336, 336′ of the implant 320 can be placed through the loops3151 and 3151′″ of the dilators 3153 and 3153′″, respectively, asindicated by the paths of the directional arrows J and G, respectively.Slidable tube members 3131 and 3131″ ‘of the dilators 3153 and 3153’,respectively, can then be slid over the loops 3151 and 3131′″,respectively, as described above. The dilators 3153 and 3153′″ can thenbe used to pull the straps 336, 336′ through, for example, the arcustendineus AT on each side of a pelvic region. The straps 334, 334′ canbe delivered in a similar manner or using any of the devices describedherein. The straps 334, 334′ can be secured, for example, to the arcustendineus or an obturator.

FIG. 56 illustrates an embodiment of an implant unassembled. A user(e.g., a physician, or medical professional) can select an implantsupport portion and a suitable sleeve and strap assembly, and assemblethem as needed. An implant 3220 can be assembled such that it isconfigured similar to the implant 1420 described above with reference toFIG. 28. The implant 3220 includes a support portion 3222 having fourcorners G, F, H, J. Although only a single sleeve and strap assembly3296 is shown, it should be understood that more than one sleeve andstrap assembly can be coupled to the support portion 3222, for example,at one or more of the corners G, F, H, J. For example, an implant can beassembled with a sleeve and strap assembly coupled at each of thecorners G and F to form an implant. In another example, a sleeve andstrap assembly can be coupled to corners H and J, to form anotherembodiment of an implant. To assemble the implant 3220, a user can cutto size and assemble the implant to his or her preference (e.g., in asterile environment).

The strap and sleeve assembly 3296 includes a strap 3238, a sleeve 3295,a suture 3242, a trocar needle 3232 and a curved needle 3249. The suture3242 is knotted or otherwise secured to an exposed portion of the strap3238 at point C, threaded in and out of the strap 3238 to point A whereit is again secured to the strap 3238 (e.g., by tying a knot). Thesuture 3242 can also be knotted intermittently along the strap 3238between points C and A. The suture 3242 continues from point A insidethe sleeve 3295 to point B where it is secured and exits the sleeve3295. The suture extends from the sleeve forming a leader 3230 to whichthe trocar needle 3232 is attached. The curved needle 3249 is secured tothe suture 3242 and can be used to sew or stitch the strap 3238 to thesupport portion 3222, for example, at corner G. After the sleeve andstrap assembly 3296 has been secured to the support portion 3222, thecurved needle 3249 and excess suture extending from the securement siteat point G can be cut off. As stated above, a sleeve and strap assemblycan be attached in the same manner at one or more of the other cornersof the support portion 3222.

The resulting implant 3220 can be implanted within a pelvic region byassociating the bullet trocar needle 3232 to a delivery device, such asdelivery device 164 and using the delivery device to pull the strapassembly 3296 through a selected tissue, such as a sacrospinous ligamentor tendineus arch of the levator ani muscle. The procedure for pullingsuch a sleeve and strap assembly through a tissue site has beendescribed above with reference to other embodiments. After the implant3220 is placed in a desired position, the suture 3242 or the sleeve 3295and suture 3242 are cut at, for example, location D, to release thesleeve 3295 from the strap 3238, and the sleeve 3295 is pulled off thestrap 3238 as previously described. If a suture portion remains attachedto the strap 3238 at point A, it can be used to retrieve a cut strapportion after trimming the strap 3238 (if needed).

The sleeve and strap assembly 3296 can also be used alone, for example,for uterine suspension or to provide vaginal apical support. In such aprocedure, the sleeve and strap assembly 3296 is placed through avaginal incision, and the strap 3238 at point C is anchored (e.g.,sutured or stitched) to the vaginal apex using the curved needle 3249and suture 3242. The bullet trocar needle 3232 is then associated to adelivery device, such as device 164, or other suturing insertion device,to pass the trocar needle 3232 through the sacrospinous ligament (SSL).The trocar needle 3232 and attached suture leader 3230 are thenretrieved and drawn outside the body by the catch of the deliverydevice. The sleeve and strap assembly 3296 is then pulled (via theleader 3230) through the SSL, or other anchoring tissue, until the strap3238 can be seen (through the sleeve 3295) to exit on the other side ofthe SSL or anchoring tissue. The sleeve 3295 and strap 3238 arepositioned and adjusted for the correct tension. Once positionedcorrectly, the leader 3230 and sleeve 3295 are cut and the sleeve 3295is gripped and pulled outward away from the body to leave the strap 3238to engage the surrounding tissue. A remnant of the suture leader 3230will still be attached to the strap 3238 at point A, and can be used toretrieve any cut portion of the strap from the body after trimming thestrap 3238 (if necessary) as previously described.

FIG. 57 illustrates an embodiment of a sleeve assembly 3354 that issimilar to the sleeve assemblies 1954 and 2054 described above. Thesleeve assembly 3354 can be coupled to a strap of an implant tofacilitate the delivery of the strap when inserted into tissue. Thesleeve assembly 3354 includes a sleeve 3326, a suture 3342, and aconnector 3347 coupled to an end of the sleeve 3226. As shown in FIG.57, the sleeve 3326 only covers a portion of a strap 3338. For example,in some embodiments, only the portion of the strap that will be anchoredin tissue is covered by the sleeve. In some embodiments, the sleevecovers substantially all of a strap.

The suture 3342 is threaded into an end portion of the strap 3338 atpoint A and forms a loop within the sleeve 3326. For example, to securethe suture 3342 to the strap 3338, two ends of the suture 3342 can bethreaded into the strap 3338 at location A. The two ends are passed backthrough a loop formed in the suture 3342 to secure the suture 3342 tothe strap 3338. The suture can alternatively be tied to the strap 3338.The suture ends are then threaded through the inside of the sleeve 3326to a location B where the suture 3342 is secured to the sleeve 3326and/or the connector 3347. For example, a heat seal can be used tosecure one end of the suture 3342 to the sleeve 3326. In otherembodiments, the suture 3342 can be molded to the connector 3347, tiedto the connector 3347, tied to one wall of the sleeve 3326, tied to bothwalls of the sleeve 3326, or otherwise secured. In this embodiment, theconnector 3347 can be used to associate to a delivery device, such asdelivery device 264 to pass the sleeve assembly 3354 (and attached strap3338) through a tissue.

After the sleeve assembly 3354 is pulled through a tissue, the suture3342 and sleeve 3326 can be cut at, for example, location C, to releasethe sleeve 3326 from the strap 3338. In some embodiments, the suture3342 can be exposed at point B (e.g., external to the sleeve 3326) suchthat only the suture 3342 need be cut to release the sleeve 3326 fromthe strap 3338. In other embodiments, the suture 3342 can run outside ofthe sleeve 3326. In some embodiments, a single strand of suture ormultiple strands of suture can be used to secure the sleeve 3326 to thestrap 3338.

FIG. 58 illustrates a sleeve assembly having a curved and/or flexibledilator. A sleeve assembly 3454 includes a sleeve 3426 coupled to adilator 3428, a leader 3430 and a trocar needle 3432. The trocar needle3432 can be used to associate to a delivery device as previouslydescribed. The dilator 3428 can be pre-formed with a curved shape or canbe flexible such that the dilator 3428 can curve or bend duringinsertion through a tissue. For example, the dilator 3428 can beconfigured to travel about 180 degrees at locations within a pelvicregion, such as through a sacrospinous ligament or arcus tendineus andout through a vaginal incision. A heat seal 3468 can be used to securethe sleeve 3426 to a strap (not shown). For example, two walls of thesleeve 3426 can be heat bonded over the strap material.

The sleeve 3426 includes windows 3445 to provide access to cut a strapdisposed within the sleeve 3426, or to cut a single wall of the sleeve3426 and the strap to release the sleeve 3426 from the strap. The sleeve3426 can then be removed by pulling the dilator 3428. If the strap andboth walls of the sleeve 3426 are cut at window 3445, the window 3445forms two flaps to allow easy grasping access for removal of the sleeveremnant. In an alternative embodiment, the sleeve 3426 can be sealedover a suture loop (not shown) threaded into the material of a strap. Insuch an embodiment, the strands of the suture loop can be arranged asfar apart as possible within the sleeve 3426 to facilitate cutting asingle strand of the suture loop for release of the sleeve 3426 from astrap of an implant. The windows 3445 can provide access to the sutureloop for cutting.

FIG. 59 illustrates an embodiment of an implant that can be used, forexample, as a urethral sling to treat, for example, incontinence. Animplant 3520 can be delivered into a pelvic region through a smallvaginal incision (e.g., a transvaginal approach). An incision can bemade, for example, along an anterior vaginal mucosa. The incision canbe, for example, 1.5 to 2.0 cm (0.59 to 0.79 inches) in length and canextend approximately 0.5 cm (0.2 inches) to the meatus. The vaginalepithelium is dissected from the underlying periurethral fascia. Theimplant 3520 is formed by attachment of two sleeve and strap assemblies3596, 3596′ to a urethral support 3522. The sleeve and strap assemblies3596, 3596′ are constructed the same as the sleeve and strap assemblies1496 and 1496′ described with reference to FIG. 28. Only the sleeve andstrap assembly 3596 is described below, as the sleeve and strap assembly3596′ is similarly constructed and can be used and removed in the samemanner as the sleeve assembly 3596.

The sleeve and strap assembly 3596 includes a sleeve 3595 disposed overa strap 3534, a suture 3542, and a loop connector 3597 (similarcomponents, 3595, 3534′, 3542′ and 3597′ are shown for sleeve and strapassembly 3596′ in FIG. 59). The strap 3534 of the sleeve and strapassembly 3596 can be secured to the urethral support portion 3522 in asimilar manner as for implant 3220 described with reference to FIG. 56.For example, a curved needle (or other type needle) can be used tosuture or sew the strap 3534 to an end of the urethral support 3522. Theconnectors 3597 can be used to associate to a delivery device, such asdelivery device 264 described herein. The sleeve 3595 can be removedfrom the strap after implantation as described above for previousembodiments. For example, the sleeve 3595 and/or suture 3542 can be cutat location C.

In some embodiments, it may be desirable to cut the implant 3520 intotwo halves, thereby creating two sleeve and strap assemblies that theuser can then attach to a selected implant. In another alternativeembodiment, a urethral support sling can have a length such that itincludes straps. A sleeve assembly as described herein can be used tohelp deliver and secure the straps of the urethral support within apelvic region.

The implant 3520 can be used in incontinence and uterine preservationprocedures as well as pelvic floor repair procedures, and for otherprocedures or a combination thereof. Other types and configurations ofsleeve and strap assemblies can alternatively be used. For example, asleeve and strap assembly can include a trocar needle to associate to adelivery device 164. The urethral support 3522 can be made from a singlepiece of synthetic mesh material, and the center portion of the mesh canbe de-tanged, with the straps (e.g., 3534) tanged for engagement withsurrounding tissue. The implant 3520 can be deployed via a vaginalapproach. The implant 3520 can be placed using various approaches, suchas a vaginal approach or a pre-pubic approach.

FIGS. 60-62 illustrate another embodiment of an implant that can beplaced in multiple different locations within a pelvic region to treatvarious female pelvic floor dysfunctions. An implant 3620 includes twosupport portions 3633 and 3637 that are separated by an opening 3639defined by the implant 3620. The opening 3639 allows the supportportions 3633 and 3637 to be spaced apart at various distancesdepending, for example, on the length and/or width of the opening.Although one opening is shown, in other embodiments, and implant caninclude multiple openings that define multiple support portions. Inanother embodiment, the implant has no opening and only a single supportportion. In yet another embodiment the support portion is wider than thestrap portion.

The implant 3620 also includes anchoring straps 3627 and 3629 thatextend from the support portions 3633 and 3637. The implant 3620 can beplaced within a pelvic region using any of the methods, devices andapproaches described herein, and the anchoring straps 3627 and 3629 canbe placed through a variety of different tissues and/or ligaments tosupport the support the support portions 3633 and 3637 in a desiredposition. The implant 3620 can also be formed with a mesh material topromote tissue in-growth as described above for previous embodiments.The two support portions 3633 and 3637 provided by the implant 3620 canreduce the number of implants needed to treat a particular prolapsecondition or to treat multiple prolapse conditions.

In one example, the implant 3620 can be placed in a pelvic region andthe anchoring straps 3627 and 3629 can be placed through an arcustendineus (i.e., white line) on contra lateral sides of the pelvicregion. FIG. 61 is a cut-away partial view of a pelvic region showinguteral sacral ligaments USL, sacrospinous ligaments SSL, a cut-away ofthe rectum R, the bladder B, and an arcus tendineus AT (on one-sideonly). As shown in FIG. 61, the implant 3620 can be placed within thepelvic region with the anchoring strap 3627 anchored to the arcustendineus AT on one side of the pelvic region. The anchoring strap 3629can be similarly secured to an arcus tendineus on the contra lateralside of the pelvic region (not shown in FIG. 61). The implant 3620 canbe secured such that the opening 3639 is spread or pulled open a desiredamount.

FIG. 62 illustrates another example of the implant 3620 placed in apelvic region. FIG. 62 is a cut-away partial view of a pelvic regionshowing uteral sacral ligaments USL, a cut-away of the rectum R, thebladder B, an arcus tendineus AT (on one side only), sacrospinousligaments SSL and a uterus U. In this example, the anchoring straps 3627and 3629 of the implant 3620 are secured to a sacrospinous ligament SSLon each side of the pelvic region. This example illustrates the use ofthe implant 3620 for uterine preservation. The implant 3620 can beplaced in a pelvic region and secured to alternative locations, such as,for example, pubo-urethral tissue, or an obturator.

FIGS. 63 and 64 each illustrate an example placement of an implantwithin a pelvic region. FIG. 63 is a cut-away partial view of a pelvicregion showing uteral sacral ligaments USL, a cut-away of the rectum R,the bladder B, an arcus tendineus AT (on one side only), sacrospinousligaments SSL and obturators O. In this example, the implant 2220described above with reference to FIG. 38 is shown placed within thepelvic region. The straps 2234 are shown placed through obturators O.The straps 2236 are shown placed through the arcus tendineus AT, and thestraps 2238 are shown placed through the sacrospinous ligaments SSL. Thevaginal wrap portion 2241 is tucked around the vaginal cuff on aposterior side of the vagina (not shown). The posterior reinforcementstraps 2267 can provide posterior apical support and the anteriorreinforcement straps 2265 can provide anterior apical support.

FIG. 64 is a cut-away partial view of a pelvic region showing uteralsacral ligaments USL, a cut-away of the rectum R, the bladder B, anarcus tendineus AT (on one side only), sacrospinous ligaments SSL andobturators O. In this example, the implant 3020 described above withreference to FIG. 51 is shown placed within the pelvic region. Thestraps 3038 of the implant 3020 are shown placed through thesacrospinous ligaments SSL and the support portion 3046 is wrappedaround the vaginal cuff.

FIG. 65 illustrates a portion of another embodiment of an implantillustrating a separator member in the form of a set of tacks. As shownin FIG. 65, an implant 3720 includes a strap 3734. A sleeve assembly3754 is coupled to and disposed over the strap 3734. The sleeve assembly3754 includes a sleeve 3726 and a tapered dilator 3728. The dilator 3728can be coupled to the sleeve 3726 as described above for otherembodiments, for example, by crimping, heat sealing, stitching,stretching, tip tipping, etc. Alternatively, the sleeve 3726 can beformed to include a portion that forms a tapered dilator. The dilator3728 can be used to expand or enlarge a passage during insertion througha tissue, to ease the transition to a cross-section or size of thesleeve 3726. The sleeve 3726 is also tapered, which also helps provide alead-in through the tissue.

The sleeve 3726 is secured to the strap 3734 with a suture 3742. Thesuture 3742 is looped within the sleeve 3726 and weaved or threadedthrough the implant 3720 at location A. The suture 3742 canalternatively be coupled to the strap 3734 using, for example, any ofthe methods described above for the dilator to sleeve coupling, forexample, by crimping, heat sealing, stitching, stretching, tip tipping,etc. In some embodiments, a suture can be threaded to or secured to astrap, for example by knotting. The strands of the sutures 3742 formingthe loop through the sleeves 3726 extend through an interior of thedilator 3728 and can be crimped closed and heat bonded to an interiorwall of the dilator 3728 (not shown in FIG. 65) to maintain the strap3734 within the sleeve 3726.

A leader suture 3730 is coupled to and extends distally from the dilator3728. Alternatively, a leader portion of the suture 3742 can extenddistally from the dilator 3728. A trocar needle 3732 is coupled to adistal end of the leader suture 3730. As described previously, thetrocar needle 3732 can be used to associate the implant 3720 to adelivery device, such as a delivery device 164 described above.

In this embodiment, the sleeve assembly 3754 includes a separator 3748in the form of a set of tacks 3723 (four tacks 3723 are shown, but otherquantities can be used) disposed between two strands of the loopedsuture 3742 and near a distal end of the sleeve 3726. The set of tacks3723 couple a top wall and a bottom wall of the sleeve 3726 together,and maintain separation of the strands of the looped suture 3742 withinthe sleeve 3726. A second set of tacks 3721 can be used to lightlysecure the strap 3734 to the sleeve 3726. As described above, theseparation of the strands of the suture 3742 enable or help facilitate acut to be made through only a single strand of the looped suture 3742at, for example, location B, during removal of the sleeve 3726. Using aset or group of small tacks (rather than a single large tack) can helpmaintain flexibility of the strap 3734 during delivery of the strap 3734into a pelvic region where it may need to fold or bend during insertion.

FIGS. 66A-66D illustrate a procedure for making an anterior incision ina vagina. FIG. 66A illustrates an initial midline anterior vaginal wallincision AI. The anterior incision AI can be, for example, about 4 cmlong extending about 1 cm from the cervix to the level of the proximalurethra as shown by the dashed line D shown in FIG. 66A. FIG. 66B showsthe incision extended to the level of the proximal urethra. FIG. 66Cillustrates a dissection and traction on the bladder. Such a sharpdissection and traction can facilitate dissection of the bladder off thevaginal wall. FIG. 66D illustrates a completed mobilization of acystocele off the vaginal wall.

FIGS. 67A-67F illustrate an example procedure for making a posteriorincision where excess tissue is excised in a vagina to treat, forexample, a rectocele. The dashed line D illustrates the area of perinealskin and posterior vaginal wall to be excised. FIG. 67B illustrates asharp dissection of the posterior vaginal wall from the anterior rectalwall. As shown in FIG. 67B, the dissection can be aided with a finger inthe patient's rectum. Also shown in FIG. 67B is the subepithelial tunnelof rectovaginal space labeled ST, and a full thickness vaginal strip tothe apex of the vagina labeled VS.

FIG. 67C illustrates various potential defects that may be encounteredat the time of a rectocele repair procedure, and FIG. 67D illustrateshow placing a finger in the rectum R and elevating the anterior rectalwall can help delineate fascial tears. FIG. 67E shows the rectovaginalfascia RVF, the anterior rectal mucosa M, and an edge of a transversedefect ETD. FIG. 67E illustrates a low transverse defect between theperineum and a distal edge of the rectovaginal fistula. The inset figurelabeled E-1 illustrates a defect-specific closure with interruptedsutures. FIG. 67F shows the rectovaginal fascia RVF, the anterior rectalmucosa M, and an edge of a midline defect EMD. FIG. 67F illustrates amidline longitudinal defect and the inset figure labeled F-1 illustratesa defect-specific closure with interrupted sutures.

The implants described herein can be formed with a variety of differentmaterials, such as biocompatible plastics and/or metals. In someembodiments, the implant is formed at least in part with a mesh materialto promote tissue in-growth. In implant can also be formed fully or inpart with biological or natural materials or combinations of biologicaland synthetic materials. An implant can be formed at least in part with,for example, the Advantage® Mesh by BSC. Alternatively, the implant canbe formed with Polyform® Synthetic Mesh material by BSC.

The sutures can be a monofilament or braided and can be formed with avariety of different biocompatible materials. For example, the suturematerial can include absorbable and non-absorbable material, and/or acombination thereof. The various other components described herein canbe formed with one or more biocompatible plastics and/or metals.

In one embodiment, an apparatus includes a support member implantablewithin a pelvic region and a strap extending from the support member.The strap has a length and is configured to be secured within a pelvictissue to support the support member within the pelvic region. A sleeveis releasably disposed over at least a portion of the strap and has alength greater than the length of the strap. In some embodiments, ofthis apparatus the length of the sleeve is at least twice as long as thelength of the strap. In some embodiments, the length of the strap issuch that the strap can be positioned at a tissue securement locationwithin the pelvic region, but cannot extend to a vaginal incision afterbeing placed at least partially through the tissue securement location,and the length of the sleeve is sufficiently long such that the sleevecan extend from the strap after being positioned at the tissuesecurement location to the vaginal incision.

The above apparatus can also include the following features. In someembodiments, the sleeve includes a first portion and a second portionthat define an interior, and the apparatus further includes a suturedisposed at least partially within the interior of the sleeve andforming two strands of suture within the interior of the sleeve. The twostrands are separated by a distance defined by a separator portion ofthe sleeve. In some embodiments, the support member is formed with afirst material and the strap is formed with a second material differentthan the first material. In some embodiments, the strap is secured tothe sleeve with a suture. In some embodiments, the sleeve includes afirst wall and a second wall defining an interior and the apparatusfurther includes a suture at least partially disposed within the sleeveand coupled to the support portion. In some embodiments, the supportmember includes a first portion that is configured to support a bladderneck and a second portion that is configured to be wrapped at leastpartially around a vaginal cuff in a posterior region of the pelvicspace. In some embodiments, the support member includes a first portionconfigured to support a bladder neck and a second portion configured tosupport a uterus. In some embodiments, the support member includes aportion configured to support a uterus.

In another embodiment, an apparatus includes a support memberimplantable within a pelvic region and a strap extending from thesupport member and configured to be secured within a pelvic tissue tosupport the support member within the pelvic region. A sleeve isreleasably disposed over at least a portion of the strap and has a firstwall and a second wall that define an interior space. A suture iscoupled to the strap and also to the sleeve. The suture is disposed atleast partially within the interior space of the sleeve and forms twostrands of suture within the interior space of the sleeve. The twostrands are separated by a distance defined by a separator portion ofthe sleeve. In some embodiments, the apparatus also includes a dilatorthat is coupled to the a distal end portion of the sleeve. In someembodiments, the sleeve defines a window and the strap is accessiblewithin the interior space of the sleeve through the window. In someembodiments, the strap is formed with a mesh material and includes atanged edge to engage tissue within a pelvic region. In someembodiments, the strap includes protrusions formed on a surface of thestrap that are configured to engage pelvic tissue to help anchor thestrap to the pelvic tissue. In some embodiments, the support member isconfigured to provide support to a bladder neck when the strap issecured to a pelvic tissue.

In another embodiment, an apparatus includes a support member that isimplantable within a pelvic region. A first strap extends from thesupport member and configured to be secured to a an arcus tendineus whenthe support member is implanted within the pelvic region. A second strapextends from the support member and distal of the first strap and isconfigured to be secured to a sacrospinous ligament when the supportmember is implanted within a pelvic region. The first strap has a lengthsuch that the first strap can be secured to the arcus tendineus butcannot extend to a vagina after being secured to the arcus tendineus.The second strap has a length such that the second strap can be securedto the sacrospinous ligament but cannot extend to the vagina after beingsecured to the sacrospinous ligament. The first strap and the secondstrap are configured to help support the support member at leastpartially beneath the bladder neck when the first strap is secured tothe arcus tendineus and the second strap is secured to the sacrospinousligament.

The above apparatus can also include the following features. In someembodiments, the apparatus can further include a tail portion thatextends from the support member and is configured to be wrapped around avaginal cuff in a posterior region of the pelvic region. In someembodiments, the apparatus further includes a sleeve disposed over atleast one of the first strap or the second strap, a dilator coupled to adistal end of the sleeve, a suture coupled to the strap and to thesleeve, and a needle coupled to a distal end portion of the suture thatis configured to associate the strap to a delivery device.

In some embodiments, the apparatus includes a sleeve disposed over atleast one of the first strap or the second strap and a suture thatcouples the sleeve to the strap. The suture has a first strand and asecond strand disposed within the sleeve and is separated by a separatorportion of the sleeve. In some embodiments, the apparatus includesshoulder extending from the support member and proximal of the firststrap and that is configured to be secured to at least one of the arcustendineus or an obturator. In some embodiments, the apparatus includes ashoulder extending from the support member and proximal of the firststrap that is configured to be secured to at least one of the arcustendineus or an obturator via a suture. In some embodiments, theapparatus includes a first dilator coupled to the first strap, and asecond dilator coupled to the second strap. The first dilator is a firstcolor and the second dilator is a second color that is different thanthe first color.

In another embodiment, a method includes inserting a pelvic implantthrough an anterior vaginal incision and into a pelvic region. Thepelvic implant includes a support portion, a strap extending from thesupport portion, and a sleeve disposed over the strap, where the sleevehas a length greater than a length of the strap. The sleeve and strapare pulled at least partially through a pelvic tissue such that a firstportion of the sleeve is disposed within the pelvic tissue and a secondportion of the sleeve extends through the vaginal incision and the strapis disposed at least partially within the pelvic tissue but does notextend through the vaginal incision. The sleeve is removed from thestrap leaving the strap at least partially disposed within the pelvictissue. In some embodiments of this method the pelvic tissue is an arcustendineus.

In another embodiment, a method includes inserting an implant through avaginal incision and into a pelvic region. The implant includes a firststrap and a second strap both extending from a support portion. Thefirst strap is placed through a sacrospinous ligament of a first side ofthe pelvic region and the second strap is placed through an arcustendineus of the first side of the pelvic region. An anterior portion ofthe support portion is secured to at least one of an obturator or thearcus tendineus of the first side of the pelvic region. In someembodiments, the implant includes a third strap and a fourth strap, andthe method includes placing the third strap through a sacrospinousligament of a second contra lateral side of the pelvic region andplacing the fourth strap through an arcus tendineus of the second contralateral side of the pelvic region.

In another embodiment, a method includes providing a pelvic implanthaving a strap extending from a support portion of the implant and thestrap has a first length. A portion of the support portion of theimplant is cut such that the strap has a second length greater than thefirst length of the strap. After cutting the implant, at least a portionof the strap is placed through a pelvic tissue to at least partiallysecure the implant within a pelvic region of a patient. In someembodiments, cutting the implant includes making a first cut on thesupport portion of the implant adjacent a first side of the strap, andmaking a second cut on the support portion of the implant adjacent asecond side of the strap. In some embodiments, the implant includes acut line disposed on the support portion of the implant to indicate alocation for cutting the portion of the support portion of the implant.

CONCLUSION

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods and steps described aboveindicate certain events occurring in certain order, those of ordinaryskill in the art having the benefit of this disclosure would recognizethat the ordering of certain steps may be modified and that suchmodifications are in accordance with the variations of the invention.Additionally, certain of the steps may be performed concurrently in aparallel process when possible, as well as performed sequentially asdescribed above. The embodiments have been particularly shown anddescribed, but it will be understood that various changes in form anddetails may be made.

For example, although various embodiments have been described as havingparticular features and/or combinations of components, other embodimentsare possible having any combination or sub-combination of any featuresand/or components from any of embodiments as described herein. Thus, thebreadth and scope of the invention should not be limited by any of theabove-described embodiments, but should be defined only in accordancewith the following claims and their equivalents.

For example, the implants described herein can be delivered andimplanted within a pelvic region using any of the devices, methods andapproaches described herein or other devices and delivery methods notspecifically described. Various delivery aids such as sleeves, dilators,connectors, etc., can be used to deliver the implants to a pelvicregion. An implant can have various other shapes, sizes andconfigurations not specifically described. Any of the implants describedherein can include tangs, dimples, protrusions or other anchoringfeatures. An implant according to any of the embodiments can beassembled to a delivery device or delivery aid by a user (e.g.,physician) or provided preassembled to the user.

In another example, any of the implants described herein can be cut to adesired size. For example, a strap and/or support portion can be cut ortrimmed to a desired size (e.g., length and/or width). The implantsdescribed herein can be used to treat a variety of different femalepelvic floor dysfunctions including, for example, cystoceles,rectoceles, enteroceles, and/or vaginal prolapses. The implants can alsobe used to treat paravaginal repairs, provide uterine support, or treatincontinence.

In addition, a fixation or placement device does not have to be includedas part of a strap, sleeve, or any other element of an implant. Forexample, an implant can be secured within tissue using other fixationmethods, such as, for example, a heating element, glue stick, or aneedle and suture. Other attachment methods include a thermal energysource, mechanical or chemical fixation techniques or a combinationthereof.

What is claimed is:
 1. A method, comprising: inserting a pelvic implantthrough an anterior vaginal incision and into a pelvic region, thepelvic implant including a support portion, a strap extending from thesupport portion, and a sleeve disposed over the strap, the sleeve havinga length greater than a length of the strap, the sleeve having a distalend portion coupled to a dilator, the dilator having an interior walldefining a lumen, the sleeve being coupled to a proximal end portion ofthe strap with a suture, the suture having a first end and a second end,the suture forming a loop having a first strand and a second strand, thesuture being woven through a portion of the support portion, the firststrand and the second strand extending from the support portion of theimplant, along the strap, and into the lumen of the dilator, a portionof the first strand and the second strand being coupled to the interiorwall inside the lumen of the dilator, the sleeve including a separatordisposed between the first strand and the second strand, the separatorincluding at least one tack that couples a top wall and a bottom wall ofthe sleeve to maintain separation of the first strand and the secondstrand; pulling the sleeve, the strap, and the dilator at leastpartially through a pelvic tissue within the pelvic region such that afirst portion of the sleeve is disposed within the pelvic tissue and asecond portion of the sleeve extends through the vaginal incision andthe strap is disposed at least partially within the pelvic tissue butdoes not extend through the vaginal incision; and removing the sleevefrom the strap and leaving the strap at least partially disposed withinthe pelvic tissue, the removing including cutting the first strand butnot the second strand, and pulling on the sleeve or the dilator toremove the sleeve, the suture, and the dilator from the strap.
 2. Themethod of claim 1, wherein the pelvic tissue is an arcus tendineus. 3.The method of claim 1, wherein the pelvic tissue is a sacrospinousligament.
 4. The method of claim 1, wherein the support portion isformed with a first material and the strap is formed with a secondmaterial different than the first material.
 5. The method of claim 1,wherein the support portion includes a first support portion supportinga bladder neck and a second support portion wrapping at least partiallyaround a vaginal cuff in a posterior region of the pelvic space.
 6. Themethod of claim 1, wherein the support portion includes a first supportportion supporting a bladder neck and a second support portionsupporting a uterus.
 7. The method of claim 1, wherein the suture iscoupled to the strap and to the sleeve, wherein the method furthercomprises: associating a needle coupled to the suture to a deliverydevice.
 8. The method of claim 1, wherein the sleeve includes a taperedportion.
 9. The method of claim 1, wherein a leader is coupled to adistal end portion of the dilator.
 10. The method of claim 1, whereinthe strap includes a plurality of dimples, wherein the location in whichthe first strand is cut is disposed between the separator and theplurality of dimples.
 11. A method comprising: inserting an implantthrough a vaginal incision and into a pelvic region, the implantincluding a plurality of straps, the plurality of straps including firstand second posterior straps, first and second mid straps, and first andsecond anterior straps extending from a support portion of the implant,wherein a separate sleeve is disposed over each strap, each sleeve has adistal end portion coupled to a separate dilator, and each sleeve iscoupled to a proximal end portion of a respective strap with a separatesuture, the suture having a first strand and a second strand, a portionof the first strand and the second strand being coupled to an interiorwall inside a lumen of the dilator, the suture being woven through aportion of the support portion, the sleeve including a separatordisposed between the first strand and the second strand, the separatorincluding at least one tack that couples a top wall and a bottom wall ofthe sleeve to maintain separation of the first strand and the secondstrand; placing the first and second posterior straps through asacrospinous ligament of the pelvic region; placing the first and secondmid straps through an arcus tendineus of the pelvic region; placing thefirst and second anterior straps through the arcus tendineus or anobturator of the pelvic region; and securing an anterior portion of thesupport portion to at least one of the obturator or the arcus tendineusof the pelvic region.
 12. A method, comprising: inserting a pelvicimplant through an anterior vaginal incision and into a pelvic region,the pelvic implant including a support portion, a strap extending fromthe support portion, and a sleeve disposed over the strap, the supportportion including a first support portion supporting a bladder neck anda second support portion wrapping at least partially around a vaginalcuff in a posterior region of the pelvic region, the sleeve including atapered portion, the sleeve having a length greater than a length of thestrap, the sleeve having a distal end portion coupled to a dilator, thedilator having an interior wall defining a lumen, the sleeve beingcoupled to a proximal end portion of the strap with a suture, the suturehaving a first end and a second end, the suture forming a loop having afirst strand and a second strand, the first strand and the second strandextending from the support portion of the pelvic implant, along thestrap, and into the lumen of the dilator, a portion of the first strandand the second strand being coupled to the interior wall inside thelumen of the dilator, the suture being woven through a portion of thesupport portion, the sleeve including a separator disposed between thefirst strand and the second strand, the separator including at least onetack that couples a top wall and a bottom wall of the sleeve to maintainseparation of the first strand and the second strand; pulling thesleeve, the strap, and the dilator at least partially through a pelvictissue within the pelvic region such that a first portion of the sleeveis disposed within the pelvic tissue and a second portion of the sleeveextends through the vaginal incision and the strap is disposed at leastpartially within the pelvic tissue but does not extend through thevaginal incision, the pelvic tissue being an arcus tendineus or asacrospinous ligament; and removing the sleeve from the strap butleaving the strap at least partially disposed within the pelvic tissue,the removing including cutting the first strand but not the secondstrand, and pulling on the sleeve or the dilator to remove the sleeve,the suture, and the dilator from the strap.